Piramal Pharma gets 3 USFDA observations for US facility
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-02-08 05:48 GMT | Update On 2024-03-21 16:00 GMT
Advertisement
Mumbai: Piramal Pharma has announced that the United States Food and Drug Administration (US FDA) has concluded a Pre-Approval Inspection (PAI) with 3 observations at the Company's Riverview (USA) facility.
The inspection was conducted from 29th January 2024 to 6th February 2024.
"On conclusion of the inspection, a Form-483 was issued with 3 observations," the Company stated in a BSE filing.
The observations were classified under VAI (Voluntary Action Indicated) and does not relate to data integrity.
"The Company is preparing a detailed response to said observations, which will be submitted to the US FDA within stipulated timelines. The Company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations," Piramal said.
Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .
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.