FDA Revokes Licence of Cipla's Pune Warehouse Over Alleged Violations
What Happened
The Maharashtra Food and Drug Administration (FDA) has cancelled the drug sale and distribution licence of Cipla Pharma & Life Sciences Ltd's carrying and forwarding warehouse in Wadki, Pune, after finding alleged violations related to the packaging, storage, documentation and recall of Reactin Plus Tablets. The action followed fresh regulatory proceedings conducted as per directions of the Bombay High Court.
Key Takeaways
The latest action intensifies regulatory scrutiny on Cipla's Pune facility, although the case relates to compliance and labelling issues. Cipla has contested the regulator's action and has previously stated that the matter does not involve product quality, efficacy or patient safety concerns.