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USFDA's Releases Notice to DRL's UK Unit

Dr Reddy's Laboratories (DRL)'s API unit in UK has now come under the scanner of the United States Food and Drug Administration, which has raised concerns over current good manufacturing practices (cGMP) at the unit. Following the audit of API Mirfield Plant, United kingdom by USFDA, many irregularities were noticed which led to issuance of Form 483.

According to USFDA, Form 483 is issued to a firm at the conclusion of an inspection when the investigator has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. The FDA Form 483 notifies the company's management of objectionable conditions.

Recently, DRL also recived warning letter from German regulatory authority Regierung von Oberbayern about cGMP violations at DRL's formulations manufacturing unit at Duvvada in Vizag and concluded its audit with zero critical but six major observations. In August, the company's formulations manufacturing Unit-2 in Bachupally too had come under German regulator's lens.

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