Cipla Receives One Observation in USFDA Inspection at Bengaluru Plant

2 Jun 2025 , 11:13 AM

Cipla Ltd has announced that the United States Food and Drug Administration (USFDA), has recently completed cGMP inspection at company’s Bommasandra manufacturing facility in Bengaluru. The inspection was carried out between May 26 and May 30, 2025, a stock exchange filing dated May 30 stated.

One Form 483 Observation Issued

The USFDA has classified the inspection as an Official Action Indicated (OAI) and issued Form 483 with one observation post the audit. Cipla said it would cooperate with the US health regulator to address the observation and provide a comprehensive response within the stipulated time. The company also reaffirmed its focus on regulatory compliance and quality system requirements at all of its facilities.

What is cGMP?

Current Good Manufacturing Practices (cGMP) are rules implemented by the USFDA to ensure that drug products are safe, effective and of good quality. Facilities that supply to the U.S. market are mandated to comply with cGMP guidelines, which cover all aspects of manufacturing and quality control.

Understanding Form 483

USFDA inspectors issue a Form 483 at the end of the inspection if they’ve observed anything that may be a violation of, or variance from, cGMP standards. These findings are preliminary and are not final action on the facility’s status of compliance. After a Form 483 is issued, the company then has 15 business days to respond and explain what it has done to fix the problems and plans to take further corrective action.

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