USFDA issues warning letter to Sun Pharma Dadra facility
Mumbai: Sun Pharmaceutical Industries Limited has received a Warning Letter from the US Food and Drug Administration (USFDA) for its Dadra facility.
"The Warning Letter summarizes violations with respect to Current Good Manufacturing Practice (cGMP) regulations. The contents of the Warning Letter shall be made public by the USFDA in due course," the Company informed in a BSE filing.
USFDA had inspected the facility from December 4, 2023 to December 15, 2023 and determined the inspection classification status of the Company's Dadra facility as Official Action Indicated (OAI). OAI means regulatory and/or administrative actions are recommended.
Read also: Sun Pharma receives OAI status from USFDA for Dadra facility
Sun Pharma is an Indian multinational pharmaceutical company headquartered in Mumbai, Maharashtra. The company manufactures and markets a large basket of pharmaceutical formulations covering a broad spectrum of chronic and acute therapies. It includes generics, branded generics, specialty, complex or difficult-to-make technology-intensive products, over-the-counter (OTC), antiretrovirals (ARVs), Active Pharmaceutical Ingredients (APIs), and Intermediates.
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.