Cipla's InvaGen Pharmaceuticals Faces USFDA Observations

Cipla's subsidiary, InvaGen Pharmaceuticals, received two observations from the USFDA following an inspection at its facility. Conducted from February 2 to February 9, 2026, the inspection resulted in Form 483 being issued. InvaGen plans to address these observations promptly in coordination with the USFDA.

Drug manufacturer Cipla reported that its US-based subsidiary, InvaGen Pharmaceuticals, has been issued Form 483 with two observations by the US Food and Drug Administration (USFDA) after a recent inspection.

The Pre-Approval Inspection was carried out from February 2 to February 9, 2026, at the InvaGen facility. The USFDA's inspection concluded with the issuance of Form 483, which is a document listing observations of potential violations of the Food Drug and Cosmetic Act.

Cipla has stated its commitment to addressing these issues promptly and in collaboration with the USFDA, ensuring compliance within the stipulated timeline.

(With inputs from agencies.)