Latest FDA and cGMP Compliance News

After many scandals and investigations over cGMP violations and many recalls, not to mention several issues over marketing tactics, J&J is now engaging in some soul searching. The health care company is now asking its employees to reflect upon their thoughts about the credo for the organization, and then take a poll so the company can identify how to improve the credo.

This news was given to J&J employees today from the CEO and the VP for HR. This comes after J&J’s first PR campaign to shore up its corporate image. Oddly enough, this new campaign was started just when J&J had a cGMP manufacturing scandal in South Korea, where criminal charges are pending.

As we have recounted here often, J&J’s image has taken a beating since 2010. In the last three years, J&J has had the following issues:

• Recalls of Tylenol, Motrin, Rolaids, Sudafed, KY Jelly, Acuevue contact lenses, syringes, hip replacement devices and glucose meters
• The Ethicon branch in 2012 stopped the marketing of 4 vaginal mesh implants that have been the focal point of 1000 lawsuits by women.
• Difficulty in keeping Tampons and anti-fungal shampoo in stock in many stores around the US

One of the biggest scandals was regarding defective hip devices and the effort to downplay the high rate of failure. Another was a kickback case that dealt with a nursing home pharmacy. Omnicare was accused of getting kickbacks so that J&J’s Risperdal would be prescribed more.

By the end of 2012, all these scandal took a real pounding on the image for J&J. A poll on corporate reputation found that J&J had dropped from first to seventh place in 2 years. Investors, though, continue to invest in the company, with the stock increasing 43% in the last year.

Latest FDA and cGMP Compliance News

FDA has decided this week that fecal transplants are indeed biologic therapy, so this means that doctors and researchers will have to submit an IND application.

Researchers who want to perform fecal transplants, which is emerging as a good therapy to treat Clostridium difficile or C. diff infections, were told of this new requirement in February.

Is this a good move? Some researchers and doctors are worried that the new requirements will add a great deal of paperwork and a 30 day wait. This could restrict access to a very promising type of therapy. One researcher at the Virginia Commonwealth University told us that the ruling will impose a massive paperwork hurdle to getting needed therapies to patients with serious C. diff infections.

An infectious disease specialist named Judy Stone agrees. She has said this week that FDA should not include non-academic and non-research centers in the IND requirement, or organizations that only want to do a few procedures each month. If not, doctors are going to give more patients DIY, do it yourself treatments at home.

Other researchers think that while there will be added expense and paperwork, they understand the need for FDA to set new safety standards for the procedures.

Latest FDA and cGMP Compliance News

If there is anything we can learn from the $9 billion deal that has Actavis buying Warner Chilcott, it is that taxes really do matter. As part of the deal, Actavis is going to place its headquarters in Ireland. In that country, the drug maker can pay a lot less in corporate taxes.

This year, Actavis will pay about 28% of its profits in corporate taxes, but by moving overseas, its tax rate will be 17%. This will provide a boost to Actavis is several ways.

Competitors that have lower taxes to pay can now buy some products at a higher price and they can absorb new deals in an area with lower taxes. They end up paying lower taxes not just today, but also down the road in future acquisitions.

This is a clear example of how high tax rates hurt businesses. The US is losing out. It is not getting the short term cash from Actavis, and it also loses out for years on future taxes from the company. Of course, Actavis will have to pay taxes on profits that occur in the US but the US treasury is going to get less tax money because of this move.

It appears that many Actavis executives will continue to live in the US though. The CEO of the firm stated that the senior management team will stay in the US. It turns out that the managers just like living in New Jersey too much.

A big reason for this deal is that Actavis will have a better chance of getting a better deal as the patent cliff approaches. Fewer patents are expiring on big name drugs, so generic makers have fewer chances to come up with cheap versions of the same drug. Warner-Chilcott will assist Actavis in diversifying into new therapeutic areas, such as women’s health and dermatology. Soon, brand name drug sales will be about 25% of yearly revenue, rather than the current 8%. This means that the revenue will climb from $600 million to $2 billion.

This can create yet more chances to take good advantage of other brand name drug buys. Now the Actavis name will more often show up on lists of potential buyers that bankers will pass around when they are speaking to clients about drugs that could be sold off. Actavis will be more likely to be in the hunt for these drugs.

Every company wants to buy up the next Lipitor but in general, experts say the generic opportunity is shrinking. Actavis does have some big name drugs, but the companies that can successfully negotiate the transition are small. Actavis is seeing that it will pay to have a presence in emerging market areas where a generic can actually become a brand.

Latest FDA and cGMP Compliance News

The Department of Agriculture has fined Bristol Myers Squibb for breaking the Animal Welfare Act due to the deaths of two monkeys in its labs. This fine was just revealed by PETA this week. That organization filed a complaint with FDA in 2012 after a whistleblower called foul on the laboratory conditions at the company.

The monkey deaths were reported earlier. In one of the cases, a macaque was left alone when it was restrained during some type of medical procedure. Why the monkey died is not known. In the other, the macaque was left in a case or cage that was in the process of being sanitized. It was left in there when the cage was put into nearly boiling water, killing the monkey.

There were a total of four violations that were noted by USDA. The agency fined the company $2600 in February. The other cases dealt with a bottle of epinephrine that was expired that was in an emergency kit, and for leaving open some food containers.

PETA has said it is satisfied for the rule violations regarding the safety and health of animals, but the group said that the fine is tiny for a firm that made $17 billion last year in sales.

However, PETA hopes that Bristol Myers Squibb will reform its care of animals and pay more attention to what is going on in its labs. USDA very rarely fines companies that violate animal protection laws. We hear that it is a very long and embarrassing process for the companies involved because the feds actually initiate a formal investigation.

Speaking of labs, we have an excellent webinar coming up on how to maintain FDA GLP compliance in your laboratory. Check it out now!

Latest FDA and cGMP Compliance News

We noted that there was a noticeable drop in the dollar value of pharmaceutical cargo thefts in 2012. Alas, it appears that this was only temporary. Our recent analysis shows that pharmaceutical thieves are having a great year in 2013. To this point, about $3.4 million in thefts have happened this year. This works out to be around $173,000 per job.

For the entire year of 2012, the amount of drugs stolen in cargo shipments was around $3 million, or $148,000 per job. This data comes from Freightwatch International, which tracks the theft of commodities.

It seems that a bit of a rebound is underway in pharmaceutical thefts. For 2011, about $12.7 million were ripped off, which is an average of $550,000 per theft. Even with all of the industry’s efforts to stop these thefts, thieves are finding new ways to have their way with the industry.

We started to take more notice of such thefts in 2010, when a stunning $75 million in drugs was taken from an Eli Lilly warehouse in Connecticut. There it appeared that the thieves had insider knowledge of the security systems. They chopped a hole in the roof to get inside the warehouse. This one robbery boosted the value of thefts in 2010 to $94 million, or $3.5 million per robbery.

These burglaries are not rare, but many security experts state that the increasing number may show that the thieves are changing up their tactics. For instance, a theft happened last week when a tractor trailer was taken from a trucker’s stop in Kentucky.

The driver went to the bathroom and when came back, the truck was gone. Tracking indicated that the truck and trailer left the site five minutes after the trucker stopped. This shows that the truck was probably followed from its origination point in New Jersey.

Keep in mind that some pharmaceutical thefts are never reported, so the total value of pharma thefts each year is higher than it appears.

Even with all of the threats that pharmaceutical companies have to deal with in terms of cGMP violations and FDA sanctions, they still have to worry about yet another problem – common thieves!

Latest FDA and cGMP Compliance News

It seems no matter how much J&J tries to put a stop to lawsuits for the marketing of Risperdal, another suit always pops up. The latest lawsuit involves the attorney general in Kentucky. He, like others before him in the state and federal government, accuse J&J of promoting Risperdal illegally.

J&J is being accused of trying to hide and to minimize data about side effects including diabetes and weight gain. It also is accused of hiding evidence that Risperdal can cause higher amounts in kids of a hormone that can stimulate breast development. At the end of 2012, J&J started to settle lawsuits that charge that Risperdal causes gynecomastia, which is the development of the breasts in males.

In one sense, this is just one lawsuit of many, but it shows just how much the marketing practices of Risperdal continue to dog J&J. The health giant is trying to overcome the bad PR that has been generated from many cGMP manufacturing snafus that caused many product recalls, as well as a major scandal over the safety of some of its artificial hip joints.

J&J continues to work with the feds over terms for a settlement of $2.2 billion. The company wants to try to avoid admitting to conduct that could cause negative effects to personal injury suits that involve gynecomastia. The feds want the company to admit that the data played down serious risks of increased production of prolactin. J&J wants the US government to agree to not to pursue this allegation.

Many other US states have forced J&J to pay in suits over the marketing practices for Risperdal. J&J paid $181 million to end claims in 35 states. Also, an Arkansas judge fined J&J a cool $1 billion. Also, J&J agree to pay out $160 million to end a lawsuit the the attorney general in Texas.

Risperdal marketing has proven to be an albatross for J&J and its CEO, Alex Gorksy. The feds in 2012 tried to force Gorsky to give a deposition in a kickback case that involved a nursing home pharmacy called Omnicare. The issue was that the pharmacy got kickbacks so that Risperdal would be more often prescribed. Gorsky was VP of marketing at the unit at Janssen that marketed the drug and he also was later the president of Janssen.

The feds also noted that Gorsky was in charge of a compliance program at Janssen for legal and regulatory issues. He also got reports each month ln the Long Term Care Group at J&J. This included reports that had many details about Omnicare attempts to push the prescription of Risperdal.

J&J also has had many product recalls to deal with of late. To learn how to avoid recalls and how to effectively mitigate their consequences, be sure to review our upcoming webinar on product recalls.

Latest FDA and cGMP Compliance News

Due to an FDA crackdown on cGMP violations and an increasing shortage of many types of prescription drugs, we are not shocked to learn that we are seeing more FDA drug recalls in the first quarter of 2013.

We have seen 107 recalls as of the end of Q1. This is a 32% boost from the last quarter.

Due to the higher scrutiny of compounding pharmacies by FDA after the fungal meningitis scare last year, a compounding pharmacy set the 2013 record so far this year with a total of 13 recalls.

There have been more than 13 million unit recalls, which is an increase from 12 million at the end of 2012. Most of this was because of several big recalls, some of which were more than 1 million units each.

There were 14 Class I recalls in Q1, which was more than occurred in all of 2012. These are the most serious recalls because FDA says there is a ‘reasonable probability’ that using these drugs will cause a serious adverse event or even death.

There also were more Class II and Class III recalls in the last quarter than in every quarter last year. There were 62 Class II recalls and 31 Class III recalls. Six recalls were involving OTC drugs and three high volume drugs accounted for more than 80% of the total.

Most of the rest of the 107 other recalls dealt with prescription drugs, and 14 of them were Class I, 61 were Class II and Class III totaled 26.

67 of the recalls affected US customers around the country.

If you want to learn how your company can prevent and deal with a drug recall effectively, please review our upcoming Webinar from the CDRH recall branch chief, Rita Hoffman.

Below are the original Expertbriefings.com cGMP and FDA-related stories for  2013.

Be sure to check out our upcoming events, too!

FDA cGMP Compliance News and Tips

1. May 21 – J&J Soul Searching – Help Us With Our Credo
2. May 21 – FDA Set to Regulate Fecal Transplants
3. May 21 – Actavis Departs to Ireland for Lower Taxes
4. May 20 – Bristol Myers Hit With Fine for Monkey Deaths
5. May 20 – Pharmaceutical Cargo Thefts on the Rise
6. May 20 – Another Risperdal Lawsuit Slams J&J
7. May 20 – Serious Drug Recalls on the Rise
8. May 16 – FDA Slams Hospira With Another Warning Letter
9. May 16 – Court Tells FDA That FSMA Deadlines Are Required
10. May 16 – How Ranbaxy Tried to Screw FDA
11. May 16 – Criminal Charges on J&J in South Korea Tylenol Case
12. May 15 – How to Improve Your CAPA System
13. May 15 – Watch Out for What You ‘Like’ – FDA Is Watching Your Facebook Page
14. May 15 – Recent FDA Warning Letter Lessons Show FDA Is Watching Facebook
15. May 15 – More Pharma Jobs Get the Axe
16. May 14 – How to Keep Up With Medical Device Demand and Keep Quality High
17. May 14 – Ranbaxy Production Scandal Costs $500 Million
18. May 14 – Why Did Senior FDA Official Leave Agency? Congressional Probe Begins
19. May 13 – New FDA Warning Letter Shows Web Content Is Extension of Labeling
20. May 13 – Fired CRO Exec Says Firm Was Tracking Sexual Orientation of Hires
21. May 13 – 5 Screw Ups That Will Delay Your FDA 510(K) Approval
22. May 13 – Novartis Playing Catch Up on Vet Drug Production Woes At Nebraska Plant
23. May 13 – Essential Tips for New FDA 510(K) Refuse to Accept Policy
24. May 8 – Bayer Warned – Pull False Vitamin Claim or We’ll Sue
25. May 8 – Eli Lilly Chops Hundreds More Sales Rep Jobs
26. May 8 – More J&J Uproar: Employees Sue for Age Discrimination
27. May 7 – Update – Tanning Bed Ban for Teens Not Off the Table, FDA Warns
28. May 7 – FDA Plans to Reclassify Tanning Beds as Class II Medical Devices
29. May 7 – Is Selling Viagra Direct Online a Good Idea?
30. May 7 – Teva Regrets Canning Worker With Brain Tumor
31. May 6 - Absolute Worst FDA Warning Letter Responses
32. May 6 – FDA Ponders – Is Tricolsan Safe?
33. May 6 – J&J Stops Tylenol Production in South Korea
34. May 6 – Caffeinated Gun Causes New FDA Investigation
35. May 3 – Scandal Over Conflict of Interest for Novartis Trial
36. May 3 – Essential Tips for Bulletproof cGMP Quality Agreements
37. May 2 – Why So Few FDA Warning Letters?
38. May 2 – Did Judge Go Too Far on Plan B Pill?
39. May 2 – Novartis Dumps OTC Drugs Produced at 483-Plagued NE Plant
40. May 2- FDA Wants Help on Think Tank for Opioid Trials
41. May 2 – Got MS? Have a Free Lunch on Novartis
42. May 1 – Raised Eyebrow Alert – High Level FDAer Leaving for Mylan
43. May 1 – FDA Deputy Commissioner Moves on to Mylan
44. May 1 – FDA Releases Ugly Novartis 483 for Lincoln NE Plant
45. April 30 – FDA Allows Access to Plan B for 15 Year Olds
46. April 30 – Give Attention to Equipment Calibration Certificates
47. April 30 – Free FDA Compliance and cGMP Reports
48. April 30 – 5 Tips for Rock Solid Supplier Controls
49. April 30 – FDA and Allergan Warn About Fake Botox from Overseas
50. April 30 – More Counterfeit Drugs Pop Up – What to Do?
51. April 29 – How to Optimize Your Quality System to Ensure FDA and ISO Compliance
52. April 29 – 3 More Tips for Excellent cGMP Plant Design
53. April 29 – The Clock Is Ticking Part 2 – 15 Days to Respond to 483
54. April 29 – Hooters and Fishing Trips for Docs – Has Novartis Violated Corporate Integrity Agreement?
55. April 29 – Senate Bill Gains Major Support to Boost FDA Muscle on Drug Compounders
56. April 25 – The Clock is Ticking – Responding to FDA 483 in 15 Days
57. April 25 – FDA Raids Cancer Clinic, Confiscates Laetrile
58. April 25 – Salesman for Fake Avastin Pleads Guilty to Felony
59. April 25 – FDA Counterfeit Device Detector Targets Fake Malaria Drugs
60. April 25 – Monkey Abuse Scandal – Harvard Shutting Down Primate Research Center
61. April 24 – Effective Project Management for Developing Medical Devices
62. April 24 – GMP Problems Result in 300 Jobs Chopped at Novartis Plant
63. April 24 – More Evidence of Link Between Autism and Antidepressants
64. April 24 – Novartis Sued by Federal Government for Massive Kickback Scheme
65. April 23 – FDA Mulls Petition to Protect Patents for Biologic Medications
66. April 23 – FDA Recognizes OxyContin Abuse with New Reformulation
67. April 23 – Congress Preparing Legislation to Improve Pharmaceutical Supply Chain
68. April 23 – FDA Blasts Teva for Overblown Marketing Materials
69. April 22 – 3 Best Practices for Strong cGMP Plant Design
70. April 22 – More Drug Compounding Recalls for Bacteria in Vials of Sterile Product
71. April 22 – FDA Wants More Regulatory Authority to Regulate Drug Compounding
72. April 22 – Aptuit Employee Busted and Jailed for Clinical Trial Data Scams
73. April 22 – Essential cGMP Quality Tips for Senior Managers
74. April 19 – The Risks of an FDA Import Alert
75. April 19 – FDA Opts for Public Safety Over Pain Med Access
76. April 18 – 5 Lab Calibration Tips – Stay Ahead of the cGMP FDA Inspector
77. April 18 – Contract Manufacturing Organization Hit with cGMP Warning Letter
78. April 18 – Revision of Clinical Trial Ethics in Helsinki Declaration
79. April 18 – FDA Guidance on Quality Agreements for CMOs Much Needed
80. April 17 – 5 Crucial Tips to Deal With an FDA Warning Letter
81. April 17 – Perfect OOS Results Will Make FDA Auditor Nervous, and Other cGMP Inspection Issues
82. April 17 – And the #1 cGMP 483 Observation for 2012 Is…
83. April 16 – cGMP Consultant Paid $1000 a Day for Assembling Binders?
84. April 16 – Why You Need a Strong Relationship with Your CMO
85. April 16 – Latest FDA cGMP Inspection Trends Highlighted at Recent Conference
86. April 15 – Stability Testing a Common Problem in FDA Warning Letters
87. April 15 – 21 CFR 211.194 – Tips for Laboratory Records cGMP Compliance for QC Labs
88. April 15 – 21 CFR 820.198- Implementing Risk-Based Management in Handling Complaints
89. April 13 – 21 CFR 820.198 – Avoiding Pitfalls in Your Complaint Handling Process
90. April 12 – Setting up Your Bulletproof MDR Files, and How to Avoid Landmines
91. April 12 – Understanding the Medical Device Reporting Regulations
92. April 10 - Expert Recommendations for FDA eCopy Submission
93. April 10 – Pfizer Hit with Warning Letter for Serious cGMP Manufacturing Problems
94. April 9 – Does My FDA eCopy Submission Meet FDA Requirements?
95. April 9 – eCTD Tips – Transitioning from Paper to Electronic Submissions
96. April 8 – Kabco Pharma Consent Decree Lesson – Provide Complete Warning Letter Reponse to FDA
97. April 8  – How to Stay Compliant with 21 CFR Part 11
98. April 8 – You May Not Even Know You Are On Import Alert
99. April 8 – 15 Simple Steps for cGMP-Compliant Quality Systems
100. April 5 – How to Ensure FDA cGMP Compliance With Employees
101. April 4 – cGMP Inspection Tip – Best and Worst FDA 483 Response Letters
102. April 4 – The Urgent Danger of Repeat 483 Observations
103. April 3- Bugs and More Bugs – an FDA cGMP Inspection Disaster
104. April-3 FDA Not Really Hammering Pharma on Social Media, Report Finds
105. April 3 – 3 Tips to Handle Non-PDF Files in Your FDA eCopy Submission
106. April 2 – Bizarre – Cancer Research Compound Robbery
107. 4 Tips for Pharma in Social Media From Former FDA Commissioner
108. More Clarity Needed on FDA eSource Trial Data Draft Guidance
109. Hospira Consent Decree Coming?
110. FDA/Customs Country of Origin Confusion on Drugs
111. cGMP Quality Agreement Tip – Remember Definitions!
112. Beg for a Warning Letter and FDA Says, “Sure!”
113. 7 Tips to Hire a Top cGMP Consultant
114. Analysis: DEA Move Could Limit How Pharma Markets Heavy Painkillers
115. Stringent PDF Requirements A Roadblock for FDA eCopy
116. More Great FDA Inspection Tips (and One Unforgettable Quote from the FDA Compliance Director)
117. Is GSK Pressure on FDA Influencing Hospira 483 Failures?
118. Tips to Perform Your Next Laboratory Quality Audit
119. FDA Inspection Close Up – Using Strong Process Mapping and Gap Analysis
120. The Death of Paper – FDA eCopy
121. PDF Problems Reported with FDA’s New eCopy Rule
122. Former FDA Recall Chief – How to Design Your Recall Strategy
123. More Tips to Survive Your FDA Clinical Inspection
124. Danger! Legal Landmines in Your Company Records!
125. Using Effective Process Mapping, Gap Analysis and SOP Review
126. 5 Do’s and Don’ts for Your Next FDA Inspection
127. Yes or No – Should You Shut Down Production During Your FDA Inspection?
128. Choppy Road Ahead for Confusing eCopy Initiative
129. Facebook Frisking Your FDA Auditor
130. Like Candy at Easter – FDA Hands Out CAPA 483 Observations
131. Industry Bafflement by CDRH eCopy Rule Continues; FDA Confused, as Well
132. Why Is CDRH’s eCopy Confusing Everybody?
133. Tip – Check Out Your Vendor Quality Before Signing the Deal
134. Why You Have to Have a Quality Agreement with Your Contractor
135. Avoid FDA – Move to Kansas
136. Avoid a CAPA File Inspection Disaster
137. How the Quality Manager Gets Fired aka the $100,000 FDA Compliance Mistake
138. Don’t Put Your Pharma Company in LA?
139. The Silent Treatment and Other Classic FDA Tricks
140. Top FDA 483 Citations – Recent Data, Plus More 806 Enforcement

Latest FDA and cGMP Compliance News

Hospira has received another warning letter from FDA, which is the latest in a string of warning letters going back 2 years.

The most recent letter is dated May 9 and details about 12 deficiencies in design and quality assurance systems for devices that FDA investigators found during an audit of the company’s HQ in Lake Forest IL. This warning letter is a result of FDA not being satisfied by the company’s responses from a January inspection.

The warning letter also found fault with the decision of Hospira to stop producing some of its IV pumps. This was disclosed earlier this month.

The letter noted that FDA did acknowledge the global device strategy of the company, but FDA noted that it had big concerns with the timelines that the company has to replace infusion pumps, including Symbiq and Gemstr with Plum A+ pumps.

The plan to replace the pumps is thought to cost about $400 billion and will be spread out over a few years.

This is the 3rd FDA warning letter to Hospira in three years, and the company has had serious cGMP and quality problems since 2011.

Hospira executives downplayed the letter during an investor presentation in Chicago. The Lake Forest facility does not manufacture devices, but is a center for handling complaints and designs. The letter should not affect the device strategy for the company in 2013. Hospira will reply to FDA within the next 10 days.

The problems noted in the warning letter have to do with problems in verification that designs of the pumps meet spec, problems with proper procedures for CAPA, record keeping and document control issues, and problems with reporting of adverse events.

For detailed information about how to bulletproof your 510(k) for your new device, check out our upcoming webinar.

Latest FDA and cGMP Compliance News

The Food Safety Modernization Act, or FSMA, has made major changes in how FDA and the government is monitoring food safety. FSMA has science based standards and controls on food companies, and it directs companies to do hazard analysis and to create strong, preventive control plans. FDA also has more powers for inspections and enforcement, and importers and the US government must really scrutinize imported foods and also foreign suppliers.

Because FSMA is so important to public health, Congress ordered FDA to issue by July 2012 7 new regs that cover critical topics:

1. Hazard analysis and preventive controls based upon risk
2. Come up with new safety regulations
3. The manufacture, processing, packing and holding of various foods on the farm
4. Protection against intentional adulteration
5. Sanitary transportation
6. Verification of foreign suppliers
7. How to select third party suppliers and ensure they are neutral

As many in the industry know, FDA has not met the deadlines for the above. Many food manufacturing companies are upset that the rules have not been made final. They want to have clear clarify on what the rules are that will be governing their companies. And, consumer advocates are upset that the delay on these rules can put Americans at higher risk of illnesses from the foods we eat.

To that end, last fall, the Center for Food Safety and the Center for Environmental Health issued a complaint against FDA in federal court. The two organizations stated that FDA had delayed the issuance of new rules against the law.

Note that FDA has missed seven deadlines to this point and still has not implemented the major food safety regs of FSMA. FDA has provided several of the delayed regs to OMB, but they have not yet been approved.

To help deal with the delay, the two nonprofits above asked the federal court to declare that FDA violated FSMA because it did not issue regulations by deadline. FDA has responded that it is working on the FSMA regulations. They have noted that the regulations are complex and take many months to get them right. Also, FDA states that OMB is reviewing several rules right now.

FDA also pointed out that it issued in January 2013 these two proposed rules: Current Good Manufacturing Practice and Hazard Analysis and Preventative Controls for Human Food” and “Standards for Growing, Harvesting, Packing and Holding of Food for Human Consumption”.

The bottom line – FDA said it didn’t break any laws.

However, the federal court has sided with the two nonprofits in this case. The court stated that FDA did not comply with the rulemaking schedule for FSMA. The court ordered both parties to meet and to talk about a proposed new deadline for the new rules.

It seems that the implementation of FSMA will move forward more quickly. Food companies need to track the rulemaking and to make sure they analyze and comment on any proposed new FSMA regs that will be governing the food industry. Stakeholders may turn in comments on the proposed rules until May 16, 2013 here: http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm.

 If you are wondering about some of the hidden dangers of FSMA, check out our upcoming Webinar – FSMA Landmines That Affect the International Food Supply Chain.