USFDA concludes inspection at Cipla arm InvaGen's New York facility with 'zero

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Cipla’s InvaGen facility in Hauppauge, New York passed a US FDA inspection October 19-22, 2026 with zero Form 483 observations

By PTI

Updated - October 23, 2026 at 10:52 AM. | New Delhi

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.

Published on October 23, 2026

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