Apotex Pharmachem India Pvt Ltd. – FDA 483, Mar 14, 2025
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
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