Dr Reddy's Labs receives USFDA EIR for Srikakulam facility
New Delhi: Drugmaker, Dr Reddy's Labs, has recently announced that the Company has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for the formulations manufacturing facility (FTO 11) in Srikakulam, Andhra Pradesh.
"The Agency has concluded that the inspection is "closed" under 21 C.F.R.20.64(d)(3)," the company stated in a BSE filing.
Medical Dialogues team had earlier reported that the USFDA had issued a Form 483 with two observations after a PreApproval Inspection (PAI) at its manufacturing facility.
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 judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
Read also: USFDA issues 2 observations for Dr Reddy's Labs Srikakulam facility
Dr. Reddy's Laboratories Ltd. is an integrated pharmaceutical company headquartered in Hyderabad, Telangana, India. Its major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management, and dermatology.
Dr. Reddy's operates in markets across the globe. The company's major markets include - USA, India, Russia & CIS countries, and Europe
Read also: Dr Reddy's Labs to acquire Slayback Pharma OTC ophthalmic product rights
