Cipla Limited has informed the stock exchanges that the United States Food and Drug Administration (USFDA) conducted a routine current Good Manufacturing Practices (cGMP) inspection at the manufacturing facility of its wholly owned subsidiary, InvaGen Pharmaceuticals Inc., located in Central Islip, Long Island, New York, USA.
The inspection was carried out from July 13 to July 17, 2026 (EDT) as part of the USFDA's routine regulatory oversight of pharmaceutical manufacturing facilities.
At the conclusion of the inspection, the USFDA issued one inspectional observation to the facility in the form of a Form 483.
Cipla stated that it is committed to working closely with the USFDA and will address the observation comprehensively within the stipulated timeline.
A Form 483 is issued when USFDA investigators observe conditions that may require corrective action. It does not represent a final regulatory determination, and companies are expected to respond with appropriate corrective and preventive actions (CAPA).
Cipla emphasized that it remains committed to maintaining high standards of quality, compliance, and manufacturing excellence across its global operations.
