Piramal Pharma Gets 3 USFDA Observations at US Facility
New Delhi: Piramal Pharma Limited has informed stock exchanges that the United States Food and Drug Administration (US FDA) conducted a Good Manufacturing Practices (GMP) inspection at the company's Sellersville facility in the United States between May 4 and May 8, 2026.
Following the inspection, the US FDA issued a Form 483 containing three observations. The company stated that during the closing meeting, inspectors recommended that the observations be classified under Voluntary Action Indicated (VAI). Piramal Pharma further clarified that none of the observations are related to data integrity issues.
The company said it is preparing a detailed response to the observations and will submit it to the US FDA within the prescribed timelines. Piramal Pharma also reiterated its commitment to maintaining high standards of regulatory compliance and said it will work closely with the US regulator to address all observations comprehensively.
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.