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Talk to a SpecialistTalk to a Specialist# Summary Aspen Pharmacare Holdings Limited's South African sterile drug manufacturing facility failed to establish adequate laboratory controls for finished pharmaceutical products, including specifications and test procedures for monitoring impurities in over-the-counter sterile drug products at release and throughout their shelf life, particularly for products containing Naphazoline Hydrochloride and Tetrahyd compounds. The FDA inspection from September 9-17, 2024 identified these Current Good Manufacturing Practice (CGMP) violations under 21 CFR parts 210 and 211, rendering the company's drug products adulterated. The facility's methods, controls, and manufacturing processes did not conform to CGMP requirements, necessitating corrective action to ensure product identity, strength, quality, and purity standards.