Cipla subsidiary clears USFDA inspection with zero observations

Drug major Cipla on Friday said the United States Food and Drug Administration (USFDA) concluded a routine inspection at the manufacturing facility of its wholly-owned subsidiary, InvaGen Pharmaceuticals Inc., in the US with 'zero' Form 483 observations.

The USFDA issues a Form 483 to a company's management at the conclusion of an inspection to notify them of any objectionable conditions or potential non-compliance observed regarding manufacturing processes, facilities, or controls.

The routine current Good Manufacturing Practices (cGMP) inspection was conducted by the US health regulator at the manufacturing facility in Hauppauge, Long Island, New York, from October 19-22, 2026, Cipla said in a regulatory filing.


"The inspection concluded with zero Form 483 observations," the filing noted.