Cipla Limited announced that the U.S. Food and Drug Administration (USFDA) conducted an inspection at its wholly-owned subsidiary, InvaGen Pharmaceuticals Inc.’s manufacturing facility in Central Islip, New York, USA. The inspection, which took place from July 13, 2026, to July 17, 2026, was a routine current Good Manufacturing Practices (cGMP) inspection. Following the inspection, the company received one observation in Form 483 and is committed to addressing it comprehensively with the USFDA.
USFDA Inspection at InvaGen Facility
Cipla Limited has disclosed that the United States Food and Drug Administration (USFDA) conducted an inspection at the manufacturing facility of its wholly-owned subsidiary, InvaGen Pharmaceuticals Inc. The facility is located in Central Islip, Long Island, New York, USA.
Inspection Details
The inspection was carried out from July 13, 2026, to July 17, 2026 (EDT). It was a routine inspection focused on current Good Manufacturing Practices (cGMP). Such inspections are standard procedures to ensure compliance with regulatory standards for pharmaceutical manufacturing.
Outcome and Commitment
Upon the conclusion of the inspection, Cipla Limited received one observation in Form 483. The company has affirmed its commitment to working closely with the USFDA. Cipla stated that it is dedicated to addressing the observation comprehensively and within the stipulated time frame. This proactive approach highlights the company’s dedication to maintaining high operational and quality standards.
Source: BSE
