Institute of Good Manufacturing Practices India®

Alkem Labs Baddi facility receives 2 USFDA observations


Alkem Laboratories Limited has achieved 2 observations from US Food and Drug Administration (FDA) for the facility in Baddi of company in Himachal Pradesh.

The company stated in a filing that USFDA had performed an inspection at the manufacturing facility of company located at Baddi, India from 17th to 21st February 2020.

The company further added that at the end of inspection, the company has achieved a Form 483 with 2 observations.

The company stated that it will put together a detailed response with adequate corrective and preventive measures to address the USFDA observations and the same is intended to be filed within the timeline mentioned by USFDA.