Ajanta Pharma Dahej facility concludes USFDA inspection with no Form 483
Mumbai: Ajanta Pharma has recently announced that the US Food and Drug Administration (USFDA) has concluded an inspection at the Company's Dahej facility with no Form 483.
The USFDA inspected the facility from 19th June 2023 to 23rd June 2023.
"This is to inform you that our formulation facility at Dahej was inspected by US FDA from 19th June 2023 to 23rd June 2023. At the end of inspection, no Form 483 was issued to us," the company informed in a BSE filing.
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.
Medical Dialogues team had earlier reported that the USFDA had concluded the inspection with 2 procedural observations at the company's formulation facility situated at Dahej.
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.