Cipla Ltd, a leading pharmaceutical company, announced today that it has been issued one inspectional observation in Form 483 by the US health regulator for its manufacturing facility located in Kurkumbh, Maharashtra.
The Form 483 is issued by the US Food and Drug Administration (USFDA) at the conclusion of an inspection when the investigator identifies conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
According to Cipla, the inspection took place as part of a routine assessment of current Good Manufacturing Practices (cGMP) from April 29 to May 8, 2024.
The company stated, "Following the conclusion of the inspection, we have received one inspectional observation in Form 483."
Cipla reassured stakeholders that it will collaborate closely with the USFDA and is committed to comprehensively addressing the observation within the stipulated timeframe.
