FDA 483 - Apothecon Pharmaceuticals Private Limited - May 01, 2026

Apothecon Pharmaceuticals Pvt. Ltd. in Padra, Baroda, Gujarat, India, was cited for numerous deficiencies during an inspection of its drug substance and drug product manufacturing. Key issues include failures in data integrity, inadequate complaint handling, insufficient raw material testing, and scientifically unsound laboratory controls. The firm also demonstrated significant shortcomings in aseptic processing validation, cleaning and disinfection procedures, environmental monitoring, equipment maintenance, production controls, and the completeness of batch records, indicating a broad lack of adherence to cGMP requirements.