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Sun Pharma gets 10 observations for Halol plant from USFDA

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A Form 483 is issued after completion of inspection of a facility and when the investigator has observed that may be in violation of the regulator’s rules.

Sun Pharmaceuticals Industries said on Monday it got 10 observations from United States Food and Drugs Administration following the conclusion of a Good Manufacturing Practices (GMP) inspection at its Halol facility in Gujarat.

The US health regulator has issued a ‘Form 483’ for the plant, it said in a regulatory update.

A Form 483 is issued after completion of inspection of a facility and when the investigator has observed that may be in violation of the regulator’s rules.

“The company is preparing the response to the observations, which will be submitted to the USFDA within 15 business days. The company is committed to addressing these observations promptly. The company remains committed to working closely with the US FDA and continues to enhance its GMP compliance on an ongoing basis,” it said.

The regulator had conducted a GMP inspection of Sun Pharmaceutical’s Halol facility from April 26 to May 9, 2022.

The Halol facility was classified as ‘Official Action Indicated (OAI)’ in March 2020, and was awaiting re-inspection from the US regulator. OAI means that the regulator expects more corrective actions should be taken by the company for that facility. However, due to the coronavirus (Covid-19) pandemic related travel restrictions, the re-inspection got delayed, and now the regulator has issued Form 483 with observations, which is an improvement over the OAI status.

The company manufactures and distributes products to the US from this facility. Following the update, shares of Sun Pharma closed down closed down 2.68% at Rs 861.60 on the BSE.

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