USFDA issues EIR for Lupin Vizag facility
The inspection closed with the facility receiving an inspection classification of "No Action Indicated".;
Mumbai: Global pharma major Lupin Limited has announced that the company has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its API manufacturing facility located in Visakhapatnam (Vizag), India.
The EIR was issued post the last inspection of the facility conducted from March 6 to March 10, 2023.
The inspection closed with the facility receiving an inspection classification of "No Action Indicated" (NAI). NAI means no objectionable conditions or practices were found during the inspection (or the objectionable conditions found do not justify further regulatory action).
Read also: IPM grew 19 percent in March, brands like Calpol, Augmentin observed highest growth: IQVIA
“We are happy to have received the EIR for our Vizag facility from the US FDA," said Nilesh Gupta, Managing Director, Lupin. “We remain committed to ensuring the high quality of our products and ensuring the safety of our manufacturing processes.”
Read also: Lupin pharmacovigilance group concludes USFDA inspection with no observations
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.