FDA 483 - Apotex Pharmachem India Pvt Ltd. - March 14, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Apotex Pharmachem India Pvt Ltd. in Bangalore was cited for significant deficiencies across its quality, production, facilities, and laboratory control systems. The inspection revealed failures in investigating out-of-specification results, inadequate cleaning and shipping validations, deficient master production records, and poor equipment maintenance and laboratory controls. These issues indicate a systemic lack of adherence to established procedures and scientific rationale, impacting the quality and purity of US-marketed APIs.
ID · 15522102-06ff-469b-9f4f-2f7ac42f712a