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Caplin Steriles' Gummidipoondi unit undergoes USFDA inspection
01-Jun-23   19:42 Hrs IST

Caplin Point Laboratories announced that the United States Food and Drug Administration (USFDA) had completed its GMP and PAI inspection of Caplin Steriles' (a subsidiary of Caplin Point Laboratories ) Sterile Injectable site at Gummidipoondi between 22 May to 31 May.

At the end of the inspection, there were four observations by US FDA. These observations are procedural in nature and the corrective and preventive actions for these observations will be presented to the US FDA within the stipulated period. The observations made were not repeat observations or related to data integrity.

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