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Glossary Term
FDA Form 483
Definition
FDA Form 483, officially titled "Inspectional Observations," is a document issued by FDA investigators to a company at the conclusion of an inspection when they observe conditions or practices that may violate the Federal Food, Drug, and Cosmetic Act or other related regulations. It identifies areas of non-compliance, prompting the company to address and correct the issues.
Relevance to the MedTech Industry
FDA Form 483 ensures that medical device manufacturers comply with regulatory requirements such as the Quality System Regulation (QSR) under 21 CFR Part 820. It serves as a mechanism for identifying and resolving compliance gaps, thereby safeguarding device safety, efficacy, and quality.
Additional Information & Related Terms
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