USFDA makes 9 observations over Wockhardt's plant in Shendra
New Delhi: The USFDA has made nine 'observations' highlighting violations of its norms at homegrown drug maker Wockhardt's new facility at Shendra in Aurangabad.
The company, whose shares slumped 15.04 per cent on NSE to close at Rs 1,287.00 today, however, said being a new unit, there is no export from the Shendra facility to the US.
"Inspection of our manufacturing unit at Shendra, Aurangabad by USFDA has since been completed. USFDA has made nine observations for which appropriate reply would be submitted to the inspecting authority in due course," Wockhardt Ltd said in a regulatory filing.
Without disclosing details of the observations, it further said: "The Shendra manufacturing unit is a new facility and presently there are no supply of products from the said unit to the US markets."
The observations were made by the USFDA in the form of Form 483, which is issued to a company management at the conclusion of an inspection, highlighting any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related laws.
It emerged yesterday that 62,555 bottles of anti-biotic Azithromycin tablets manufactured by Wockhardt are being recalled by PD-Rx Pharmaceuticals Inc in the US market.
The tablets are in the strengths of 250 mg (45,022 bottles) and 500 mg (17,533 bottles)
The company, whose shares slumped 15.04 per cent on NSE to close at Rs 1,287.00 today, however, said being a new unit, there is no export from the Shendra facility to the US.
"Inspection of our manufacturing unit at Shendra, Aurangabad by USFDA has since been completed. USFDA has made nine observations for which appropriate reply would be submitted to the inspecting authority in due course," Wockhardt Ltd said in a regulatory filing.
Without disclosing details of the observations, it further said: "The Shendra manufacturing unit is a new facility and presently there are no supply of products from the said unit to the US markets."
The observations were made by the USFDA in the form of Form 483, which is issued to a company management at the conclusion of an inspection, highlighting any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related laws.
It emerged yesterday that 62,555 bottles of anti-biotic Azithromycin tablets manufactured by Wockhardt are being recalled by PD-Rx Pharmaceuticals Inc in the US market.
The tablets are in the strengths of 250 mg (45,022 bottles) and 500 mg (17,533 bottles)
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.