Cipla Gets 1 USFDA Observation for New York Pharma Plant
Mumbai: Drug major Cipla Limited has informed the stock exchanges that the United States Food and Drug Administration (USFDA) has completed 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.
According to the regulatory filing, the USFDA inspection was carried out over a five-day period from July 13, 2026, to July 17, 2026 (EDT). The inspection was conducted as part of the agency’s routine cGMP inspection programme to assess compliance with manufacturing quality standards.
At the conclusion of the inspection, the USFDA issued one inspectional observation to the facility in the form of a Form 483. The company stated that it will work closely with the USFDA and is committed to addressing the observation comprehensively within the stipulated timeline.
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