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USFDA completes inspection at Caplin Point Lab’s sterile injectable facility in Tamil Nadu


USFDA completes inspection at Caplin Point Lab’s sterile injectable facility in Tamil Nadu

New Delhi: Caplin Point Laboratories said the US health regulator has completed the inspection at its sterile injectable facility in Gummudipoondi in Tamil Nadu and not issued any observations.

“The United States Food and Drug Administration (USFDA) has conducted an inspection at our sterile injectable site (CP-IV) located at Gummudipoondi from August 30 to September 06, 2018,” Caplin Point Laboratories said in a BSE filing.

“This was a scheduled inspection and at the end of the inspection, there were ZERO 483s,” it added.

As per the USFDA, form 483 notifies the company’s management of objectionable conditions based on observations made by its investigators about conditions or practices which would “indicate that any food, drug, device or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health”.



Source: PTI
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