USFDA inspects two units of Aurobindo Pharma; makes observations
New Delhi: Aurobindo Pharma said two of its facilities have undergone inspection by US health regulator USFDA, which has issued observations for one unit.
"The said facilities underwent pre-approval inspection by the United States Food and Drug Administration (USFDA) and there was no Form 483 issued to unit III. With regard to unit VII, there were certain observations," Aurobindo Pharma said in a filing to BSE.
The company however did not provide any details about the observations made by FDA.
"The company is appropriately responding and this has no perceived impact on operations and exports from the said facility," it added.
The company's unit III facility is a multi-product oral dosage form facility while unit VII formulations facility in Hyderabad manufactures oral non-antibiotic products.
"The said facilities underwent pre-approval inspection by the United States Food and Drug Administration (USFDA) and there was no Form 483 issued to unit III. With regard to unit VII, there were certain observations," Aurobindo Pharma said in a filing to BSE.
The company however did not provide any details about the observations made by FDA.
"The company is appropriately responding and this has no perceived impact on operations and exports from the said facility," it added.
The company's unit III facility is a multi-product oral dosage form facility while unit VII formulations facility in Hyderabad manufactures oral non-antibiotic products.
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.