FDA 483 - Pharmathen International S.A. - November 21, 2025

The provided document describes the purpose and legal basis for an FDA Form 483, rather than detailing specific findings from a company inspection. An FDA Form 483 is a report issued by an FDA inspector to an establishment's management at the conclusion of an inspection. It outlines observed conditions or practices that, in the inspector's judgment, indicate that products within the facility may be adulterated—meaning they consist of filthy, putrid, or decomposed substances, or have been prepared, packed, or held under insanitary conditions. These conditions could potentially lead to product contamination or render them harmful to health. The legal authority for issuing these observations is rooted in Section 704(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act. The primary objectives of the Form 483 are to formally report objectionable findings and to assist inspected firms in achieving compliance with FDA regulations. As this text provides a general overview, it does not include details such as a specific company name, inspection dates, particular violations, or any company-specific required actions.