 "FDC receives two observations from USFDA for Waluj plant")
Drug firm FDC Ltd has received two observations from the US health regulator related to current good manufacturing practice (cGMP) norms for its manufacturing facility situated at Waluj in Maharashtra.
The US Food and Drug Administration (USFDA) has completed the inspection of the company's manufacturing unit situated at Waluj on July 1, FDC Ltd said in a regulatory filing. “The USFDA has made two minor observations for which appropriate steps shall be taken by the company,” it added.
The USFDA carried out the audit of the facility in relation to cGMP norms and the abbreviated new drug application (ANDA) filed by the company for dorzolamide ophthalmic solution from the unit, it said. The company said it has also received the Establishment Inspection Report (EIR) from the USFDA for its manufacturing unit situated at Baddi, Himachal Pradesh with 'no observations'.
The receipt of EIR confirms the closure of inspection conducted in the facility in February this year.
The US Food and Drug Administration (USFDA) has completed the inspection of the company's manufacturing unit situated at Waluj on July 1, FDC Ltd said in a regulatory filing. “The USFDA has made two minor observations for which appropriate steps shall be taken by the company,” it added.
The USFDA carried out the audit of the facility in relation to cGMP norms and the abbreviated new drug application (ANDA) filed by the company for dorzolamide ophthalmic solution from the unit, it said. The company said it has also received the Establishment Inspection Report (EIR) from the USFDA for its manufacturing unit situated at Baddi, Himachal Pradesh with 'no observations'.
The receipt of EIR confirms the closure of inspection conducted in the facility in February this year.
"The said audit was carried out in relation to cGMP inspection and ANDA filed by the company for product Cefixime 400 mg tablet," the drug firm said.