Avoid the dreaded Form 483 by ensuring your facility meets FDA regulations
The FDA has the authority to conduct inspections of U.S. facilities without a warrant. Even foreign facilities are subject to inspection. Manufacturers, distributors, repackagers, relabelers, and specification developers in the dietary supplement, food, drug, medical device, or animal drug or food industries can be inspected at any time.
Any minor violations the FDA notices are written on Form 483 Inspection or Inspectional Observations. Major violations will receive a Warning Letter.
The FDA field agent conducting the inspection notes whether your facility meets the Good Manufacturing Practices (GMP) outlined by the FDA. It’s important to make sure that your products are not adulterated or improperly labeled. Serious violations can lead to a recall, which can be devastating for many businesses.
If you receive a Form 483, you must respond within 15 days of the inspection. Your response is evaluated by a Compliance Officer, who decides on the next steps, which can include a Warning Letter, recall, seizure, or in a serious case, an injunction.
With a breadth of FDA experience helping clients navigate inspection enforcement, we can help you prepare a response to Form 483 so you can get back to growing your business.
Don’t delay — you only have 15 days to respond once you’ve been inspected.
How We Help
Are you in trouble with the FDA?
Don’t panic — you’ve got backup. Download 5 Tips to Help You Navigate FDA Enforcement and learn how to resolve the situation now.
Expert knowledge of FDA regulations that helps you strategically grow your business
Marc Sanchez has provided our company with expert advice and letters that have saved us time and money in dealing with the FDA. We have worked with many FDA attorneys and consultants in the past and they can't hold a candle to the knowledge and expertise that we have found with Marc.
Jeff Maier (VP Sales & Marketing)
I am truly impressed… Marc understands the workings of the regulatory agencies and this allows him to very effectively achieve the results that his customers want without creating an environment of confrontation. Beyond that, he has insight into the laws governing foods, supplements, and medicine that goes beyond that of the federal officials involved in these regulatory areas. This allows him to open avenues of compromise and agreement that would not have existed before he was brought to bear on the difficulty. Even as he produces compromise and agreement, it is clear that he holds his customer's interest at heart.
I have never found a more powerful and effective counsel.
Steven Frank CEO
Nature's Rite Remedies
We retained Marc to answer some extremely time-sensitive and complex questions regarding COVID-19 and FDA regulations. Despite being overloaded with clients, Marc was very responsive and was able to provide us with the comprehensive answers we needed within 24 hours. This enabled us to respond quickly and effectively to the changing regulatory landscape. I strongly recommend using Marc and look forward to working together again in the future.
Marc is incredibly intelligent, poised and able to make reasonable, timely recommendations about risk. Additionally, he is extremely organized, has a calm demeanor and has provided insightful counsel to me on many regulatory issues. I strongly recommend him.