New Delhi: Pharma major Cipla Ltd on Wednesday said it has received inspection observation in Form 483 from the US health regulator for its manufacturing facility in Kurkumbh, Maharashtra.
According to the U.S. Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator observed any conditions that may violate the Food Drug and Cosmetic (FD&C) Act and related regulations. Might be possible.
Cipla said in a regulatory filing that a routine Current Good Manufacturing Practice (cGMP) inspection was conducted by the USFDA from April 29, 2024 to May 8, 2024 at the company's manufacturing facility in Kurkumbh, Maharashtra.
"At the conclusion of the inspection, the company has received an Inspection Observation in Form 483," it said.
Cipla said the company will work closely with the USFDA and is committed to comprehensively address this observation within the stipulated time.
According to the U.S. Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator observed any conditions that may violate the Food Drug and Cosmetic (FD&C) Act and related regulations. Might be possible.
Cipla said in a regulatory filing that a routine Current Good Manufacturing Practice (cGMP) inspection was conducted by the USFDA from April 29, 2024 to May 8, 2024 at the company's manufacturing facility in Kurkumbh, Maharashtra.
"At the conclusion of the inspection, the company has received an Inspection Observation in Form 483," it said.
Cipla said the company will work closely with the USFDA and is committed to comprehensively address this observation within the stipulated time.
