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It is the responsibility of the FDA to comply with public protections. Warning letters are part of a process that allows individuals and companies to take appropriate action before enforcement action is taken.

Due to the expectation that most companies and individuals will voluntarily comply with the law, this warning letter and advance notification guidelines were introduced. You can search FDA tentatively approved drug lists from various online sources.

FDA Warning Letters

Warning letter issued in case of serious violation. It is the agency's primary tool in achieving rapid voluntary compliance with the Federal Food, Drug, and Cosmetics Act (Act).

It reads: a list of observations made by FDA representatives during an inspection of your facility. This is an inspection and is not the final decision by the agency regarding your compliance.

If you are a recipient of the FDA letter 483, you will need to contact the FDA. As you handle each item, you will need to provide approval by providing a schedule for adjustments or seeking clarification of FDA requirements if necessary. 

The number of working days is 15. Regardless of the number of observations sent, a response may not be mandatory. 

However, if you can get good results, it will really help companies avoid FDA warnings or other procedures like product retention approvals or exits from installation.

Basic Information About FDA Warning Letters