Pharmaceuticals major Dr Reddy's Laboratories, on October 5, said that US health regulator had issued Establishment Inspection Report (EIR) for company's active pharmaceutical ingredients (API) manufacturing plant at Bollaram, Telangana.
The receipt of EIR indicated closure of the audit of the Bollaram facility, it added.
The US Food and Drug Administration (USFDA) classified inspection of Bollaram facility as Voluntary Action Initiated (VAI), which means the health regulator found objectionable conditions, but these issues are not considered to be of regulatory significance.
The USFDA had completed an audit of API manufacturing plant 2 on July 12 this year and issued a Form 483 with five observations.
Form 483 is generally issued to the firm's management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
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