Why Should You Close Out a Form 483 Observation Notice or Warning Letter?

Warning Letter closeout

Why Should You Close Out a Form 483 Observation Notice or Warning Letter?

We’ve heard over the years frequent enough advice given by some other GMP/FDA consultants (and even some lawyers) to companies in the food and supplement sectors, to not petition to close out a Form 483 or Warning Letter, should one get issued. Think about that for a minute! What? Why not, pray tell? Allegedly it’s an “invitation for the Agency to come back sooner,” but that is severely flawed logic for several reasons. Since we aren’t mind readers and can only speculate as to their real motivations behind giving such poor business advice, rather what we can do is give some legit reasons and insights to carefully consider for why you should take such regulatory actions seriously and work to close them out properly, albeit aggressively.

If you’ve never been through an FDA inspection, they ain’t fun folks. They are very stressful for everyone involved, especially if you don’t have a robust and efficient quality/compliance program. The FDA DOES NOT CARE if you have a GMP Certificate on the wall, or if your vendor does either! Rest assured, this will be a future topic to expand on. If the Agency has only sent you a deficiency notice e.g. for website claims, no FSVP, etc., just know, you are on their radar. Unfortunately, they don’t care how small a company you may be, if the company is under new management, if the company has just moved, if you run your business out of your home, or whatever personal hardships exist(ed) for not operating in compliance at the time of inspection/notice – they just want your operations and labeling to be compliant, so there are safe and compliant products in the marketplace, period.

Here are several of the key reasons to be aware of when it comes to your business and brand, in dealing with a regulatory action:

1. Brand damage – Nothing challenges customer loyalty and erodes brand confidence like an open warning letter contradicting your “high quality” claims
2. Loss of business/revenue – Loss in revenue from customers, distributors, and major retailers is real, and it happens quick
3. Insurance premiums go up – Prepare for a 30-50% or more hike in your policy costs; failing to report it could lead to having a claim denied later
4. Recall possibility – Whether voluntary or not, these are stressful, expensive, and wasteful generally speaking, and not having the right insurance…big loss!
5. Unexpected turnover – Stressing everyone out when it could have been prevented from the start…don’t be surprised if talent checks out 
6. Unprecedented costs (for Regulatory Consultants, Lab Testing, Reworks, etc.) – It is not cheap, so do it right the first time!
7. DWPEs – Importing ingredients/finished products into the US? A Detention Without Physical Examination will get issued with an open Warning Letter
8. Funding/Acquisition Delay or Failure – Lose investor confidence or deal with a 483 or Warning Letter hitting…say goodbye to negotiating power!
9. Lawsuits or Class actions – The single most common event that gets brands compliant more than any regulatory action, even if it doesn’t go to court, an open 483 or warning letter says it all!

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Claims Substantiation & Development

REJIMUS generates the most robust Claims Substantiation Dossiers available in the industry today. These dossiers provide technical regulatory reviews for your specific claims that can be understood by everyone within your organization. Learn More

Product Recall Support

REJIMUS offers expert recall management for food, beverages, supplements, and cosmetics. To understand more about recalls of ingredients or finished product recalls, please contact us to discuss your situation and determine the next steps in properly closing out your recall. 
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What is MoCRA?

The Cosmetics Industry has been growing tremendously, and the regulation of cosmetics has not kept until now. The Modernization of Cosmetics Regulation Act of 2022 was passed to expand the FDA’s authority of regulating cosmetic products. We can help. Learn More

Other Updates

REJIMUS will be at VitaFoods in Geneva, Switzerland. For our international based clients and other companies interested in streamlining their quality and compliance efforts with ingredients or finished products being exported to the United States, let’s have a discussion about how to improve that overall strategy and effort.

Here’s a quick snapshot of upcoming events or shows with various team members that will be attending…can we schedule a time to connect?