The US FDA inspected Unit 3 of InvaGen Pharmaceuticals at Central Islip in Long Island, New York, from July 13 to July 17, 2026. Cipla disclosed the classification in a regulatory filing dated August 28.
The VAI classification indicates that the inspection has been placed in a category where the regulator has identified issues requiring voluntary corrective action, rather than formal regulatory action. Cipla’s filing does not disclose the specific observations made during the inspection or details of any corrective measures.
InvaGen Pharmaceuticals Inc., which operates the facility, is a wholly owned subsidiary of Cipla. The inspection covered the company’s Unit 3 manufacturing facility in Central Islip, Long Island.
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Maharashtra FDA cancels Pune facility licences
The development comes a day after the Maharashtra Food and Drug Administration cancelled the drug sale licences of Cipla Pharma & Life Sciences’ Carry & Forwarding facility at Wadki in Pune, effective August 27.
The action followed an inspection linked to Reactin Plus Tablets, with the regulator citing discrepancies in stock records, storage deficiencies and non-compliance with directions to recall the medicine. The FDA also said stock worth ₹11.19 lakh was seized from Cipla Pharma & Life Sciences’ main warehouse in Wadki in June.
Maharashtra FDA Commissioner Tukaram Mundhe said the regulator would not show leniency on issues concerning drug safety and public health. He said legal requirements governing the advertising, sale, storage and distribution of Schedule H medicines must be followed, and that action would be taken under the law where violations are found.Cipla Pharma & Life Sciences has contested the order and said the matter is sub judice. The company said the FDA order did not allege concerns over the safety, quality or efficacy of its products or indicate any patient safety issue.
