An FDA Form 483 or simply 483 is used to document and communicate concerns discovered during an inspection. The FDA is authorized to perform inspections under Federal Food, Drug, and Cosmetic Act, Sec. 704 (21 USC §374).
When is an FDA form 483 issued?
Form 483 is issued to firm management at the end of an inspection when the Investigator has observed things that may have potentially violated the Federal Food, Drug, and Cosmetic Act. These observations based on the Investigator’s judgment are intended to be clear, specific, and significant. Companies that receive a 483 should respond in writing quickly with their corrective action plan and implement it as soon as possible. Companies have only fifteen days to initially respond to a 483.
Is this form intended to be an all-inclusive list of deviations from law and regulations?
No. Investigators can only report on what they saw during the inspection. There may be other questionable or unknown conditions that may have to be addressed. Companies are responsible to take corrective action to address the cited objectionable conditions and any related non-cited objectionable conditions that might exist.
What are the implications of 483 and what happens next?
FDA Form 483 does not constitute a final agency determination whether any condition is in violation of the FD&C Act or any other relevant regulations. FDA considers several sources in order to make a final agency determination. These sources are the FDA Form 483, a written report that follows 483 called an Establishment Inspection Report, all documentation or evidence collected onsite, and any responses made by the company. Then, the agency determines what further action, if any, is needed to protect public health.