Cipla Faces Fresh FDA Blow, Pune Warehouse Drug Licences Cancelled
FDA officials said inspections found misbranding and storage lapses at Cipla’s Wadki warehouse, leading to cancellation of its wholesale drug sale license.
- On Friday, the Maharashtra Food and Drug Administration cancelled the drug sale and distribution licences of Cipla Pharma & Life Sciences Ltd's warehouse at Wadki in Pune following detection of alleged violations involving Reactin Plus Tablets.
- Regulatory action followed findings of misbranding; packaging carried unauthorized claims describing Reactin Plus as an 'Analgesic and Anti-inflammatory', violating the Drugs and Cosmetics Act.
- Inspectors identified significant storage deficiencies including absence of the prescribed Form 35 inspection book, dust accumulation on drug stocks, and discrepancies between computerised SAP records and physical inventory.
- FDA Commissioner Tukaram Mundhe stated the department's objective is to "ensure the safety and quality of medicines and statutory compliance in the drug supply chain", noting proceedings followed Bombay High Court directions.
- This order replaces an earlier FDA action taken on August 27 this year, which Cipla contested; authorities completed the latest process while providing the company an opportunity for a hearing.
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Cipla Pune Warehouse Licence Cancelled: FDA Flags Misbranded Reactin Plus, Drugs Stored on Floor | 📰 LatestLY
The Maharashtra Food and Drug Administration (FDA) has cancelled the drug sale and distribution licences of Cipla Pharma & Life Sciences Ltd’s carrying and forwarding (C&F) warehouse at Wadki in Pune, citing alleged irregularities involving the packaging of Reactin Plus tablets, medicine storage, documentation and inventory management. 📰 Cipla Pune Warehouse Licence Cancelled: FDA Flags Misbranded Reactin Plus, Drugs Stored on Floor.
Cipla faces fresh FDA blow, Pune warehouse drug licences cancelled
The Maharashtra Food and Drug Administration (FDA) has cancelled the drug sale and distribution licences of Cipla Pharma & Life Sciences Ltd's carrying and forwarding (C&F) warehouse in Pune. This action follows alleged violations related to packaging, storage, documentation, and recall of Reactin Plus Tablets, a Schedule H drug. The FDA cited issues like misbranding, inadequate storage conditions, and deficiencies in record-keeping, reiterating…
FDA cancels wholesale drug sales license of Cipla Pharma & Life sciences Ltd
According to the FDA commissioner, the aim of the FDA is not merely to take regulatory action, but to ensure the safety and quality of medicines and statutory compliance throughout the drug supply chain.
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