FDA 483 - Glenmark Pharmaceuticals Limited - June 22, 2026
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Glenmark Pharmaceuticals Limited, a drug manufacturer in Colvale, India, was cited for significant deficiencies across its manufacturing and quality control operations. The inspection revealed issues with inadequate cleaning procedures, lack of validated disinfectant contact times, and insufficient controls over computer systems and data integrity. Additionally, the firm failed to properly test high-risk components, maintain adequate environmental controls, and conduct comprehensive annual product reviews and risk assessments.
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