Alkem Labs' Chakan facility gets six observations in USFDA inspection, no data integrity issues

Alkem Laboratories announced its subsidiary Enzene Biosciences received a Form 483 from the USFDA. The inspection at the Chakan manufacturing unit resulted in six procedural observations. The company highlighted zero observations related to data integrity. Enzene is preparing its response to the USFDA within the given timeline. Corrective actions are also being initiated.

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