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Sun Pharma's Halol facility concludes USFDA audit with 10 observations

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Sun Pharmaceuticals Industries announced that the US FDA conducted a Good Manufacturing Practices (GMP) inspection of the company's Halol facility (Gujarat, India) from 26 April to 09 May 2022. At the conclusion of the inspection, the US FDA issued a Form-483, with 10 observations. The Company is preparing the response to the observations, which will be submitted to the US FDA within 15 business days.

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First Published: May 10 2022 | 11:52 AM IST

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