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Florida CMO Flagged by FDA for Unjustified Process Deviations

Axara Pharmaceuticals has not justified deviations from process control procedures that resulted in drug products gone astray and equipment cleaning confusion, according to an FDA Form 483. The Hialeah, Fla.-based contract manufacturer could not account for 106 missing units of suppository-based drugs after the plant’s production manager delivered a finished batch of 259 directly to the company’s CEO without notifying quality personnel about the deviation from written procedures, the form states. The deviation had not been approved by quality personnel.
Drug GMP Report