FDA 483 Warning Letters
A Compliance Officer’s Guide to Surviving the Storm
We’re always asked about FDA 483 and warning letters – What are they? Are we going to get shut down? Is this the end of my job?
While some of you may chuckle about these questions – they represent the real fear from a lot of your staff. The term “warning” literally means “a threat or sign of impending danger”; so you can understand why people have real concern with regard to the letter from the government stating “Warning”.
The United States Food and Drug Administration defines a Warning Letter as
“…a correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations. Typically, a Warning Letter notifies a responsible individual or firm that the Agency considers one or more products, practices, processes, or other activities to be in violation of the Federal Food, Drug, and Cosmetic Act (the Act), its implementing regulations and other federal statutes. Warning Letters should only be issued for violations of regulatory significance, i.e., those that may actually lead to an enforcement action if the documented violations are not promptly and adequately corrected. A Warning Letter is one of the Agency’s principal means of achieving prompt voluntary compliance with the Act.”
What is a FDA Warning Letter?
When the US FDA finds that a firm has significantly violated FDA regulations (e.g. – 21 CFR, Parts 210, 211, 11, 820, etc.), the FDA notifies the firm via a “letter”. The Warning Letter identifies:
The letter also makes clear that the firm must correct the problem and provides directions and a time-frame for the company to inform FDA of its plans for correction. FDA then checks to ensure that the company’s corrections are adequate.
Free FDA Warning Letter Action Package
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Video On How To Handle FDA Warning Letter And Survive
How To Handle FDA Compliance Issues
We have helped hundreds of companies with their FDA inspection notice, 483 observation letter, FDA Warning Letter, and Consent Decree. Based on our years of experience, we compiled a quick guide to help you with your FDA Compliance.