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Sun Pharma Halol unit gets 10 observations under USFDA Form 483

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Sun Pharma Halol unit gets 10 observations under USFDA Form 483

US FDA has conducted a Good Manufacturing Practices (GMP) inspection of Sun Pharmaceutical Industries Limited Halol facility Gujarat from April 26 to May 9, 2022. At the conclusion of the inspection, the US FDA issued a Form-483, with 10 observations.

FDAs Office of Regulatory Affairs (ORA) is the lead office for all field activities, including inspections and enforcement. During an inspection, ORA investigators may observe conditions they deem to be objectionable. These observations are listed on an FDA Form 483 when, in an investigator’s judgment, the observed conditions or practices indicate that an FDA-regulated product may be in violation of FDA’s requirements.

Sun Pharma said, "The Company is preparing the response to the observations, which will be submitted to the US FDA 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."

In December 2019, the US FDA inspected Halol facility and issued Form 483 with 8 observations. Following submission of the Company’s response in January 2020, the USFDA classified the inspection status as Official Action Indicated (OAI).


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