The FDA issued a warning letter to an API manufacturer in Gujarat, India for using untested water in manufacturing and for invalidating an out-of-specification test result without justification.
CTX Lifesciences didn’t confirm the water it used in certain steps of its parenteral grade API was suitable for use, the agency’s investigation revealed. The investigator said that the firm was aware that its non-sterile API products were to be used in sterile injectable drug manufacturing but failed to monitor the water used in its rinse steps for endotoxins.
Additionally, the firm invalidated an out-of-specification test result for a batch of API product listed in a pending drug application, but offered no scientific justification. The company claimed it conducted an investigational study, but the FDA found it to be inadequate.