Ajanta Pharma Dahej facility gets 2 procedural observations from USFDA
The formulation facility was inspected by USFDA from 5th September 2022 to 9th September 2022.;
Mumbai: Ajanta Pharma has recently announced that the US Food and Drug Administration (USFDA) has concluded the inspection with 2 procedural observations at the company's formulation facility situated at Dahej.
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: NPPA panel fixes MRP of Ajanta Pharma Metoprolol Tartrate, lvabradine Hydrochloride FDC
The formulation facility was inspected by USFDA from 5th September 2022 to 9th September 2022.
"At the end of the inspection, Form 483 was issued to us with 2 procedural observations. We are in the process of responding to the same within the stipulated time prescribed by USFDA," the company stated 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.