Cipla arm New York facility gets EIR from USFDA
Mumbai: Cipla has announced that the New York manufacturing facility of InvaGen Pharmaceuticals Inc., a wholly-owned subsidiary of the Company, has received the EIR (Establishment Inspection Report) from the US Food and Drug Administration (USFDA) on the classification of the inspection as Voluntary Action Indicated (VAI).
Voluntary action indicated (VAI), means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action
The USFDA had inspected the facility from 11th September, 2023 to 19th September, 2023 and issued five inspectional observations.
Read also: USFDA issues 5 observations to Cipla US arm
"In furtherance to intimation dated 20th September, 2023 for United States Food and Drug Administration (USFDA) inspection at the manufacturing facility of InvaGen Pharmaceuticals Inc., wholly owned subsidiary of the Company (“InvaGen) located in Central Islip, Long Island, New York, USA, we hereby notify that the Company has received the EIR (Establishment Inspection Report) from the USFDA on the classification of the above-referred inspection as Voluntary Action Indicated (VAI)," Cipla informed in a recent 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.