Divi’s Laboratories gets form 483 citing six procedural observations from USFDA

20 Sep 2017 Evaluate

Divi’s Laboratories’ Unit-2 has been inspected by US Food and Drug Administration (USFDA) from September 11 to September 19, 2017. This inspection was for full cGMP and verification of all Corrective Actions proposed against the previous Inspection observations. All previous observations have been confirmed as completed and resolved.

On completion of this inspection, the company has received a Form 483 citing six observations which are procedural and the company will be responding to these within the stipulated time.

Divis Laboratories focussed on developing new processes for the production of Active Pharma Ingredients (APIs) & Intermediates. The company in a matter of short time expanded its breadth of operations to provide complete turnkey solutions to the domestic Indian pharmaceutical industry.

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