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The USFDA has issued a form 483 with 10 observations after inspection of Sun Pharma's Halol facility. The unit, however, now has a low contribution to the company’s turnover. The Halol facility was classified ‘Official Action Indicated (OAI)’ in March 2020, and was awaiting re-inspection from the US regulator. Due to the pandemic related travel restrictions, the re-inspection got delayed, and now the USFDA has issued a form 483 with observations. Sun Pharma said that the US Food and Drugs Administration (USFDA) did a Good Manufacturing Practices (GMP) inspection of Sun Pharmaceutical Industries Halol facility in Gujarat from April 26 to May 9, 2022. 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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