Cipla Limited announced that a routine inspection by the United States Food and Drug Administration (USFDA) at its subsidiary InvaGen Pharmaceuticals Inc.’s manufacturing facility in Hauppauge, New York, concluded on October 22, 2026. The inspection focused on current Good Manufacturing Practices (cGMP) and resulted in zero Form 483 observations, indicating compliance with regulatory standards.
USFDA Inspection Concludes Positively at InvaGen Facility
Cipla Limited has reported the successful conclusion of a routine inspection conducted by the United States Food and Drug Administration (USFDA) at its subsidiary, InvaGen Pharmaceuticals Inc.’s, manufacturing facility. The facility is located in Hauppauge, Long Island, New York, USA.
Inspection Details and Outcome
The inspection, which took place from October 19, 2026, to October 22, 2026 (ET), focused on current Good Manufacturing Practices (cGMP). A key positive outcome of this inspection is that it concluded with zero Form 483 observations. This indicates that the facility is in compliance with the stringent regulatory requirements set forth by the USFDA.
InvaGen Pharmaceuticals Inc. is a wholly owned subsidiary of Cipla Limited. The successful outcome of this inspection is crucial for maintaining regulatory compliance and ensuring the uninterrupted supply of pharmaceutical products manufactured at this site.
Source: BSE
