One of the few large Indian drugmakers that had so far avoided regulatory actions from the U.S. FDA, Cipla has been served nine FDA observations for its Indore-based manufacturing unit as part of an inspection that was conducted over the summer.
Specifically, FDA inspectors noted that the quality control unit at the central India facility lacked authority to review production records in order to check for and investigate errors. This issue was particularly notable because an out-of-specification error for levalbuterol inhalation solution resulted in a voluntary recall in May 2015, when Cipla (who manufactured the drug for Dr Reddy's Labs) recalled 140,625 vials of the solution in the U.S.
Additionally, a failure related to a leakage was documented 35 times but no investigation was initiated to identify problems. The plant was also cited for its facility and equipment systems, with inspectors noting that the aseptic processing areas were deficient in terms of the system for monitoring environmental conditions.
Read the ET article