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Talk to a SpecialistTalk to a SpecialistShree Jaya Laboratories PVT. LTD., an active pharmaceutical ingredient (API) manufacturer in India, failed to maintain adequate cleaning procedures and controls for manufacturing equipment and facilities, resulting in contamination and carry-over of materials that compromised product quality. During a September 2024 inspection, investigators found equipment documented as "cleaned" that still contained excessive colored residues and product discharge contamination, indicating the company's cleaning procedures did not prevent material carry-over beyond established specifications. These significant deviations from Current Good Manufacturing Practice (CGMP) rendered the company's APIs adulterated under the Federal Food, Drug, and Cosmetic Act.