In a major setback, Dr Reddy’s Laboratories has received 13 observations from the US Food and Drug Administration (USFDA) for its Duvvada plant in AP. It had recently received three observations for its Telangana plant. “The audit by USFDA was completed on March 8, 2017 for this plant. The company has been issued a Form 483 with 13 observations, which the company is addressing,’’ according to a source in the know. The company did not give details on nature of the observations. The FDA issues a Form-483 if its investigators spot any conditions that in their judgment may constitute violations of the US Food Drug and Cosmetic (FD&C) Act and related Acts.
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The USFDA inspected the oncology formulation facility called Unit-7, located in Visakhapatnam Special Economic Zone (VSEZ) at Duvvada. The Unit-7 is also under a warning letter. The Duvvada site manufactures cytotoxic and hormonal injectables and is an important plant given Dr Reddy’s focus on complex generic filings.
Recently, Dr Reddy’s had received three Form-483 observations from the US Food and Drug Administration (USFDA) for its Miryalaguda active pharmaceutical ingredients (API) plant in Telangana. While the company did not explain the nature of these observations, the Miryalaguda plant is one among the three plants for which the company received warning letter in November 2015. Incidentally, the company has earmarked about $40 million investment as part of remediation costs to be spent over an year and address the quality issues.