USFDA observations to keep Alkem Labs in focus

| Updated on August 23, 2019


Alkem Laboratories on Friday said that after completing inspection of its manufacturing unit in St. Louis, Fenton Park, US, and the Baddi unit in India by the USFDA, it has received Form 483 with four observations for the US facility, and zero observation for Baddi.

Alkem Labs will put together a detailed response with adequate corrective and preventive measures to address the USFDA observations for the US facility, it added. Investors will closely monitor the response.

Published on August 24, 2019

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