Cadila Pharmaceuticals Limited has received a Warning Letter from the US Food and Drug Administration based on the agency’s inspection of the company’s facility in Ankleshwar, Gujarat, India, on March 24 to 28, 2014. The company was cited for violations from current good manufacturing practices (cGMP) as it related to investigating the root cause of an odor from one of its batches in active pharmaceutical ingredient (API) manufacturing. In its letter, the FDA said that it conducted a review of the firm's response dated April 10, 2014 and noted that it lacked sufficient corrective actions and noted additional correspondence dated May 2, 2014 and June 30, 2014. 

The agency said that the company failed to fully investigate and implement corrective actions related to complaints since 2011, specifically citing a customer complaint for an unpleasant odor for a particular batch of API. The FDA’s said that the company’s investigation into this complaint concluded that the control of a known impurity may be related to the odor detected, and the investigation was closed in October 2011 before the implementation of the proposed corrective actions. In addition, the FDA said that the investigation did not provide data to support the company’s conclusion, thereby providing no assurance that the changes to the manufacturing process, implemented in response to the odor complaints, were correlated to the odor issue. The FDA noted that the company received another customer complaint for an unpleasant odor for API batches in August 2012 and that the company concluded that it was a process impurity. The FDA said that the related data from the company’s investigation was not retained and that reintegration results were provided.  

The FDA further stated that the company’s investigation related to the out-of-specification (OOS) result for the maximum unknown impurity for the API batch had concluded that the impurity had been carried over from a raw material used in the API manufacturing process. This agency said that the investigation did not address the failure of the quality unit to recognize this impurity OOS prior to release. The agency also cited the firm for data-integrity issues as it related to not having proper controls for certain analytical instruments to prevent unauthorized manipulation of electronic raw data.

Source: FDA