The FDA 483 Form is the basic document given to companies after an FDA inspection. It lists possible violations and becomes the basis for enforcement actions directed by the Office of Regulatory Affairs (ORA).

The issuance of an FDA 483 Form may follow a BIMO (Bioresearch Monitoring) inspection of a clinical site, a PAI (Pre-Approval Inspection) or a biennial cGMP inspection of a facility. The FDA investigator will list deviations from applicable regulations that are “inspectional observations”. The investigator should not list deviations from guidance documents because they are not inspectional observations, but could include such remarks in his/her written EIR (Establishment Inspection Report) to FDA.

After receipt of an FDA 483, a company can address the noted observations at a closeout meeting with the inspector. If the company believes the FDA inspector made a mistake, it may present evidence supporting its position. The inspector might annotate the observation listed on Form 483 if the company convinces the inspector the observation was a mistake.

The company is not required to file a written response to the FDA 483 notice, but doing so is usually in the company’s best interest. FDA authority allows the Agency to take additional actions against the company regardless of whether the company replies to the FDA 483 notice.

The written response from the company should include reasons why company personnel think the observations are incorrect. The response should also provide supporting evidence. If the company agrees with the observations, the response should include corrective measures and a corresponding timeline for implementation.

Communicating with FDA is vital to avoiding onerous enforcement actions such as :

• issuance of a warning letter
• Suspension or withdrawal of product approvals and
• Product seizures

FDA should be notified even if the corrective measure outlined in the written response will not be accomplished within the specified timetable. Proactive communication demonstrates to FDA that your company is trying to comply with all regulations and requirements. FDA often will work with you to meet that goal.


If your company :

• Has received an FDA 483 notice,
• Been requested by FDA to initiate a drug recall,
• Received an injunction notice,
• Would like to conduct a mock FDA audit to determine readiness, or
• Would like an opinion on whether a drug product is adulterated or misbranded

Contact the professionals at Regulatory Affairs Associates (RAA). Call today for a free initial consultation on your current regulatory issues.