FDA 483 - Steriscience Specialties Private Limited - August 19, 2013

An FDA inspection of Agila Specialities Pvt Ltd, Beta Lactam Division, in Bangalore, India, revealed significant deficiencies in manufacturing practices. Observations included inadequate record-keeping for vial labeling and API reconciliation, as well as issues with process validation for drug products. Additionally, unnecessary activities were noted during the fill line assembly, indicating potential operational inefficiencies and quality control concerns.