USFDA inspection closure report for Dr. Reddy’s facilities
The Hindu
Issue of the EIR indicates closure of the inspection, the company said
Pharma major Dr. Reddy’s Laboratories has received establishment inspection report (EIR) from U.S. Food and Drug Administration for two formulations manufacturing facilities in Visakhapatnam.
Issue of the EIR indicates closure of the inspection, the company said in an update to the stock exchanges on the USFDA audit of the facilities (FTO 7 and FTO 9) in Duvvada, Visakhapatnam.
In October, Dr. Reddy’s had said USFDA audit of the formulations manufacturing facilities was completed and a Form 483 with eight observations was issued by the regulator, “which we will address within the stipulated timeline.” The USFDA issues Form 483 to intimate the management of the objectionable conditions observed during inspection of a facility that may constitute a violation of the norms.
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