Drug firm Dr Reddy's Laboratories today said the US health regulator has issued one observation after the inspection of a unit of its Srikakulam formulations facility. The "audit of our formulations Srikakulam Plant (SEZ) Unit I, Andhra Pradesh, by the United States Food and Drug Administration (USFDA) has been completed today", Dr Reddy's Laboratories said in a filing to BSE. The company has been issued a Form 483 with one observation, which it is addressing, it added. Dr Reddy's Laboratories, however, did not disclose details about the observation. As per the USFDA, an "FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts". It notifies the company's management of objectionable conditions.
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