Months after the FDA pointed out manufacturing concerns at a Cipla plant in India—including workers using dirty disposable socks that may have caused contamination—the drugmaker said it was ready to make amends. But apparently, those remedies didn't go far enough for the FDA's liking.
The FDA knocked Cipla for failing to address cross-contamination and out-of-spec shipments for drugs produced at the manufacturer's sterile products plant in Goa, India, according to a warning letter (PDF) published Tuesday.
In its Feb. 25 letter, the FDA accused Cipla of not addressing observations raised in the administration's Form 483 following a site inspection in September.
In those observations, the FDA said product residue was found around HEPA filters and on equipment. Investigators 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 FDA said. The administration gave Cipla 15 days to offer updated responses, threatening to withhold acceptance of new drug applications and halt exports to the U.S.
In a filing to the National Stock Exchange of India Limited earlier this month, Cipla said it would "work closely with the agency to comprehensively address all the observations," but the FDA apparently wasn't satisfied with its responses.
The warning letter accused Cipla of offering corrective actions that showed "no assurance that the scope of your evaluation was comprehensive." The FDA required Cipla to create comprehensive response plans that addressed cross-contamination in some of its sterile products, out-of-spec products being delivered and a lack of written procedures to prevent microbial contamination.