Cipla's InvaGen Facility Clears USFDA Inspection With Zero Form 483 Observations
New Delhi: Pharmaceutical major Cipla Limited announced that its wholly owned subsidiary, InvaGen Pharmaceuticals Inc., has successfully concluded a routine inspection by the United States Food and Drug Administration (USFDA) at its manufacturing facility in Hauppauge, Long Island, New York, USA, with zero Form 483 observations.
According to a regulatory filing by Cipla, the inspection was conducted from October 19 to October 22, 2026, Eastern Time (ET). The inspection was part of the USFDA’s routine assessment of compliance with current Good Manufacturing Practices (cGMP).
The inspection concluded without any Form 483 observations, indicating that the USFDA did not issue observations identifying potential regulatory concerns during the inspection.
The outcome marks a positive regulatory development for InvaGen’s manufacturing operations in the United States. Regulatory inspections assess pharmaceutical manufacturing facilities for compliance with quality standards and applicable manufacturing requirements.
