Pharmaceutical giant Cipla Ltd disclosed on Wednesday that it has received one inspectional observation in Form 483 from the US health regulator for its manufacturing facility located at Kurkumbh in Maharashtra. This development comes after a routine current Good Manufacturing Practices (cGMP) inspection conducted by the US Food and Drug Administration (USFDA) at the said facility.
Form 483 is a document issued to a firm’s management at the conclusion of an inspection, indicating any conditions observed by the investigator that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
Cipla elaborated in a regulatory filing that the inspection at its Kurkumbh manufacturing facility took place from April 29, 2024, to May 8, 2024. Upon the conclusion of the inspection, the company was notified of one inspectional observation in Form 483.
The pharmaceutical company emphasized its commitment to cooperating with the USFDA and assured that it would address the observation comprehensively within the stipulated time frame. This development underscores the importance of maintaining stringent quality standards in pharmaceutical manufacturing and regulatory compliance to ensure the safety and efficacy of pharmaceutical products.
