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Dr Reddys gets EIR from USFDA for Srikakulam unit


Dr Reddys gets EIR from USFDA for Srikakulam unit

New Delhi: Dr Reddy’s Laboratories said it has received an establishment inspection report (EIR) from the US health regulator for a unit at its Srikakulam formulations facility in Andhra Pradesh.

“With regard to the audit of the company’s formulation Srikakulam Plant (SEZ) Unit I, Andhra Pradesh…the company have received an EIR from the USFDA, for the above-referred facility,” Dr Reddy’s said in a regulatory filing.

The USFDA issues an EIR to the establishment that is the subject of an FDA or FDA-contracted inspection when the agency decides to close the inspection.

In June this year, the US health regulator had issued one observation after the inspection of the unit. Dr Reddy’s, however, did not disclose details about the observation.



Source: PTI
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