Cipla Ltd, announced on Friday (June 21) that its manufacturing facility in Goa, India, underwent an inspection by the US Food and Drug Administration (USFDA) from June 10 to June 21, 2024. Following the inspection, Cipla received six inspection observations documented in Form 483.
“The USFDA conducted an inspection at our manufacturing facility in Goa, India from June 10th to June 21st, 2024. Upon conclusion of the inspection, we received six inspectional observations in Form 483,” stated Cipla in a regulatory filing.
The company assured stakeholders of its commitment to working closely with the USFDA to comprehensively address these observations within the specified timeframe. “We will collaborate closely with the USFDA and are dedicated to resolving these issues comprehensively within the stipulated time,” the statement affirmed.
Understanding Form 483: Key Details
Form 483 is an essential part of the regulatory process overseen by the USFDA. It comprises observations noted by USFDA inspectors during their inspection of facilities. These observations are communicated and discussed with the company during the closing conference.
It is important to note that Form 483 does not signify the USFDA’s final decision on whether a facility complies with Good Manufacturing Practices (GMP). Following the issuance of Form 483, the company has 15 days to submit a response to the USFDA, outlining the corrective actions it plans to take to address the observations.