Intas Pharma Sanand plant gets USFDA warning letter
"Our investigators observed plastic bags filled with torn and discarded original CGMP documents in your quality control scrap area under a stairwell, in your general parenteral scrap room, and on a truck outside your facility," USFDA said.;
Advertisement
Ahmedabad: The US health regulator has pulled up Intas Pharmaceuticals for manufacturing lapses, including failure of its quality control unit to ensure CGMP compliance, at its Sanand-based manufacturing plant. In a warning letter dated July 28, 2023, the US Food and Drug Administration (USFDA) pointed out various manufacturing lapses at the plant.
"This warning letter summarises significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals," the USFDA said.
It further said: "Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated.
The USFDA inspected the manufacturing facility from November 22 to December 2, 2022.
A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations.
The USFDA said the company "failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity."
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.