FDA Issues Warning Letter to CadilaBy
The US Food and Drug Administration (FDA) has posted a Warning Letter for good manufacturing practice (GMP) violations for finished pharmaceuticals of two Cadila pharmaceutical manufacturing facilities in India following inspections of those facilities in 2014. The facilities are in Ahmedabad, India.
The facilities were inspected in August/September and December in 2014. The agency cited for the firm for not adequately investigating out-of-specification (OOS) results, citing OOS reports associated with potency and content uniformity specifications for warfarin sodium. The agency also said that its inspection found that the firm did not adequately investigate and address consumer complaints on multiple occasions. The agency said that over a three-year period, the firm received nine consumer complaints related to potential mix-ups among products produced at its facility. Complaints were reported by different pharmacies and distributors. During the company’s investigations of these complaints, the agency said the company documented that some of the mixed-up drugs were manufactured on adjacent equipment lines, but that it never completed the root cause analysis, and therefore it is unknown whether the mix-ups were caused by inadequate cleaning procedures, personnel flow, equipment suitability, material flow, line segregation, line-clearance documentation, or something else.
The FDA also said that the firm failed to establish written procedures to monitor the progress and control the performance of processing steps that may cause variability in the quality characteristics of its active pharmaceutical ingredients (APIs), citing a problem with four batches of a particular API. The agency also said that the firm failed to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, citing a problem in controlling the use of computerized systems in the quality control laboratory.
Source: Food and Drug Administration