FDA regulatory enforcement is the process by which the agency monitors and enforces compliance with 21 CFR regulations. As an independent federal agency established by Congress, the FDA possesses executive authority and access to the federal judicial system. Through internal policies, such as the Regulatory Procedures Manual, the FDA employs various enforcement methods. Failure to promptly address issues identified during inspections or by licensees can lead to serious civil and criminal consequences. Some of the FDA's most common enforcement approaches include:

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• A Form FDA 483 is issued to an entity's management at the conclusion of an inspection when an investigator has observed conditions that, in their judgment, "may" constitute violations of the Food, Drug, and Cosmetic (FD&C) Act.

• In contrast, the FDA issues Warning Letters when it identifies significant violations of regulations by a manufacturer. While the FDA provides an opportunity for the recipient to address the issues, it also warns of potential adverse consequences and subsequent proceedings if the violations continue, such as consent decrees and injunctions.

 

Services offered by Prologos Law:

• FDA Administrative Proceedings

• Action Indicated Notices

• Response to formal and informal FDA requests and questions

• Preparation of witnesses, management and SME personnel

• Form 483 response and remediation support

• Warning Letter response and remediation support

• Assistance with Consent Decree orders

• Training