FDA 483 - Pfm Medical Cpp SA - July 09, 2018

This document, released under FOIA request 2018-6794, outlines the fundamental purpose and regulatory framework of an FDA Form 483. While specific details such as a company name, inspection dates, or particular violations are not present in this excerpt, it clarifies that the form is issued to report objectionable conditions and practices observed during an inspection. The regulatory basis for the FDA Form 483 is Section 704(b) of the Federal Food, Drug, and Cosmetic Act (21 USC 374(b)). This section mandates that an inspecting officer provide a written report to the owner or agent in charge, detailing any conditions that indicate products (food, drug, device, or cosmetic) may be adulterated—for example, by consisting of filthy, putrid, or decomposed substances, or being prepared, packed, or held under insanitary conditions that could render them injurious to health. The primary objective of issuing a Form 483 is to assist the inspected firm in complying with the Acts and regulations enforced by the Food and Drug Administration. A copy of this report is provided to the firm and subsequently sent to the Secretary.