When an inspection of Cipla’s sterile injectable plant in Goa, India, went badly last fall, it appeared pretty certain a warning letter would follow. The inspection report, after all, went on for 38 pages, detailing equipment layered in residue and bacterial contamination. The bad news has now arrived.
The Indian drugmaker confirmed (PDF) in a filing Wednesday that it had received a warning letter for the September inspection of the sterile products plant in Vasco Da Gama in Goa state. It said it “will work closely with the agency to comprehensively address all the observations” but didn't mention there were a dozen of them, many targeting shoddy cleaning methods and microbial contamination.
In fact, the first observation goes on for 11 pages, detailing multiple instances in which product residue was found around HEPA filters and on equipment. The highly redacted Form 483 also criticized the plant for using non-dedicated equipment to make and ship products to the U.S. Inspectors also noted bacillus contamination, saying it may have occurred from the use of dirty disposable socks.
There were also smoke study concerns and issues with how the plant’s quality assurance unit dealt with unexplained integrity testing discrepancies in the filling area.
The warning letter for the plant in India comes as the Indian drugmaker is trying to make headway elsewhere. Last year, Cipla formed a Chinese joint venture with local firm Jiangsu Acebright Pharmaceutical, keeping 80% of the venture for itself. It said the new company would build a manufacturing facility that would make respiratory products for the Chinese market.