Dr Reddy's Labs gets USFDA EIR for Middleburg facility
Mumbai: Pharma major, 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 its Active Pharmaceutical Ingredient (API) manufacturing plant at Middleburg, New York, indicating closure of the audit and the inspection classification of this facility is determined as 'Voluntary action indicated' (VAI).
Voluntary Action Indicated (VAI) means objectionable conditions or practices that were found but the agency is not prepared to take or recommend any administrative or regulatory action.
"Further to our intimation dated March 10, 2021 with regard to the audit of our API manufacturing plant at Middleburg, New York, we would like to inform you that we have received the Establishment Inspection Report (EIR) from US FDA, for the above-referred facility, indicating closure of the audit and the inspection classification of this facility is determined as 'Voluntary action indicated' (VAI)," the company said in a BSE filing.
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.