India’s Cadila found a ray of sunshine in the fact that the FDA had issued more than a dozen observations during an inspection of its formulation plant in Moraiya, a plant that is operating under an earlier warning letter. It says none of the observations were repeats nor involved data integrity issues.
The drugmaker made the disclosure (PDF) in a stock exchange filing, saying the 14 observations came out of a two-week inspection that was wrapped up by the agency Friday. It says it is “confident” in its ability to fix the issues, but investors didn’t seem to share the drugmaker’s optimism, dragging Cadila’s stock to a 52-week low, Indian media reported.
RELATED: Cadila reports Ahmedabad plant gets EIR from FDA, specifies it’s not part of Moraiya site
The Moraiya plant, its largest that makes drugs for the U.S. market, was one of two that were hit with a warning letter in late 2015 for a variety of shortcomings. Problems have been found at other Cadila facilities as well, including at a sterile injectables plant.
The Liva Pharmaceuticals injectables plant in Vadodara, India, was cited with a Form 483 with five observations during a product-specific inspection. Liva is a wholly owned manufacturing facility of Indian drugmaker Cadila. Issues included problems with product sterility procedures, deficiencies in monitoring environmental conditions, lack of proper training for employees and problems with its record-keeping processes.