USFDA Cites Alkem Subsidiary's Chakan Facility with Six Observations on Form 483

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USFDA Issues Form 483 with 6 Observations to Alkem Subsidiary's Chakan Plant

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News18•16-02-2026, 17:30

USFDA Issues Form 483 with 6 Observations to Alkem Subsidiary's Chakan Plant

•USFDA issued a Form 483 with six observations to Alkem Laboratories' wholly-owned subsidiary, Enzene Biosciences.
•The observations followed a pre-approval inspection at Enzene Biosciences' Chakan manufacturing unit, concluding on February 13, 2026.
•Alkem noted that there were zero observations related to data integrity, validating its quality systems.
•Enzene Biosciences is preparing its response to the USFDA and has begun corrective actions.
•Form 483 indicates potential violations of the Food, Drug and Cosmetic Act observed during an inspection.

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