When India's Cadila Pharmaceuticals got complaints from customers about some of its APIs smelling bad, the drugmaker decided the odor stemmed from an impurity, so it tweaked the manufacturing process. The problem, according to the FDA, is that the plant never conducted an investigation to determine whether the impurity was in fact the cause, so the company never knew whether it had really resolved the cause of the stench.
On several occasions, the plant had manufacturing issues, sometimes for having more than the allowable number of impurities, that it did not adequately investigate, the FDA said in a warning letter, issued Oct. 15 to a Cadila plant in Gujarat. There were three observations and other issues laid out in the letter, which the FDA posted today.
The FDA said the plant failed to put in place adequate controls to prevent API contamination that customers discovered. The plant was also chided for not protecting testing data from being deleted by employees. In addition, the inspectors said the plant was behind on testing stability samples in 2014. The drugmaker has said it has taken or is in the process of taking steps to address all of the FDA concerns, but the FDA said those steps do not go far enough.
In a statement emailed Nov. 12, the company said, "We at Cadila Pharmaceuticals Limited are following up with the US FDA on all their queries and are in the process of complying with all their requirements and addressing whatever issues raised by them. We have always maintained the highest global level quality at all our manufacturing plants and will ensure that these best of standards are always maintained."
- here's the FDA warning letter