Last Updated on December 22, 2024 by The Health Master
Form 483
Indian pharmaceutical giant Cipla Ltd. announced on June 21, 2024, that the U.S. Food and Drug Administration (USFDA) conducted an inspection of their manufacturing facility in Goa, India, from June 10th to June 21st, 2024 and issued Form 483.
Following the inspection, Cipla received six inspectional observations documented in a Form 483.
This news may be of interest to stakeholders in the pharmaceutical industry, particularly those involved in drug manufacturing, Current Good Manufacturing Practice (CGMP) compliance, and the USFDA regulatory process.
Cipla to Address USFDA Observations in Form 483
In a regulatory filing, Cipla stated, “We hereby notify that the USFDA has conducted an inspection at the company’s manufacturing facility in Goa, India from 10th – 21st June 2024.
On conclusion of the inspection, the company received six inspectional observations in Form 483.”
The company has assured its stakeholders that they will work closely with the USFDA to comprehensively address these observations within the designated timeframe.
Their statement added, “The Company will work closely with the USFDA and is committed to addressing these comprehensively within the stipulated time.”
Understanding Form 483 in the USFDA Regulatory Process
For those unfamiliar with the USFDA regulatory process, a Form 483 is a critical document.
It serves as a list of observations made by USFDA inspectors during a facility inspection and is issued upon completion.
These observations are communicated and explained to the company during a closing conference.
It’s important to note that a Form 483 is not a final determination by the FDA regarding a facility’s cGMP compliance.
What Happens After a Form 483 is Issued?
Following the issuance of a Form 483, the company has 15 days to submit a written response to the USFDA.
This response should detail the specific steps the company will take to resolve the observations outlined in the form.
By staying informed about such regulatory actions, investors and industry professionals can make more informed decisions regarding pharmaceutical companies and their compliance with international manufacturing standards.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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