In the company’s statement, the United States Food and Drug Administration (USFDA) has issued a Form 483 with ten observations after inspection of Sun Pharma’s Halol facility. Presently, the company has a low contribution in their turnover.

In March 2020, the classification of the Halol facility will be ‘Official Action Indicated (OAI)’ and was awaiting re-inspection from the US regulator. Due to the coronavirus (Covid-19) pandemic related travel restrictions, the re-inspection got delayed, and now the USFDA has issued Form 483 with observations, which is an improvement over the OAI status.

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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 on May 9, 2022, from April 26, the share market gave notification.

As per Sun Pharma’s statement, “After the inspection, the USFDA issued a Form-483, with ten observations. The company is preparing the response to the observations, which will be submitted to the US FDA within 15 business days.” The company has addressed the observation and remains committed to working closely with USFDA.

Previously, Sun Pharma’s Halol facility has been under the USFDA. Also, in the December quarter after the warning call, the company was expecting the re-inspection of the site soon, said Sun Pharmaceuticals’ MD Dilip Shanghvi.