The Maharashtra Food and Drug Administration (FDA) on Friday said it 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 following detection of alleged violations.
The action was taken after completion of fresh proceedings in compliance with the directions of the Bombay high court, the FDA said in a statement.
It follows an earlier FDA action taken against the facility on August 27 this year over alleged irregularities involving the packaging, storage, documentation and recall of Reactin Plus Tablets.
The FDA had then cited unauthorised claims on the packaging of the Schedule H prescription drug and several deficiencies at the warehouse.
The latest order was passed on October 1 by the Assistant Commissioner (Drugs), Division 3, FDA Pune, after the department withdrew its earlier proceedings in compliance with the directions of the Bombay high court, the FDA said.
According to the statement, the department issued a revised show-cause notice to the company on September 4.
Cipla submitted its written reply on September 11 and was given a personal hearing on September 21.
The licensing authority considered the company’s reply, submissions made during the hearing, inspection findings, available records and applicable legal provisions before passing the fresh order. — PTI