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USFDA completes inspection of Caplin's Sterile Injectable site at Gummidipoondi

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Caplin Steriles, the wholly owned subsidiary of Caplin Point Laboratories, announced that the US FDA has completed inspection of its Sterile Injectable site at Gummidipoondi between 6 June and 14 June 2019. At the end of this scheduled GMP inspection, there were only two observations. The Company believes these to be of procedural in nature and the corrective and preventive actions for these observations will be presented to the US FDA shortly. The observations made were not repeat observations or related to data integrity.

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First Published: Jun 17 2019 | 11:31 AM IST

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