FDA 483 - Aurolife Pharma, LLC - February 12, 2020

Aurolife Pharma, LLC received a Form 483 citing nine observations related to significant deficiencies in their manufacturing and quality control operations. Issues included inadequate contamination prevention, failure to follow quality unit procedures, insufficient product release testing, and incomplete investigations into out-of-specification results. The observations highlight systemic problems with process controls, deviation management, laboratory practices, equipment cleaning, and the absence of required annual product reviews, indicating a broad lack of GMP compliance.