FDA 483 - Pharmathen International S.A. - March 09, 2022

The U.S. Food and Drug Administration (FDA) conducted an inspection of Pharmathen International S.A. from February 28 to March 9, 2022. This inspection resulted in a Form 483, detailing three significant observations concerning the firm's compliance with manufacturing quality standards.

Key issues identified include deficiencies in the cleaning and disinfection procedures for aseptic processing areas. Specifically, the company's cleaning SOP (SOP-PR-001) did not specify the required contact times for disinfecting agents, creating uncertainty about the effectiveness of disinfection processes. Additionally, laboratory controls were found to be inadequate, as the firm failed to inspect a defined number of injectable product vials for visible particulates prior to batch release, a critical step for product quality.

Further, the Quality Assurance unit's responsibilities were not fully met. The unit did not perform periodic audit trail reviews of electronic data from the Quality Control laboratory, contradicting their own established procedure (SOP-QC-001-AUDTR). These observations indicate a need for improved adherence to Good Manufacturing Practices (GMP).

Pharmathen International S.A. is required to address these findings by developing and implementing robust corrective actions to ensure compliance in cleaning protocols, product inspection, and quality assurance oversight to maintain product safety and quality.