Barcelona-based Infar received a Form 483 from the FDA for inadequate testing procedures, record-keeping, and sanitation.
The agency conducted an inspection of the active pharmaceutical ingredient firm’s facility in January 2016 and found it lacked protocols for retesting active drug project samples. In addition, the firm’s out of specification investigations did not look for a root cause for laboratory errors.
The inspection also turned up insufficient records of investigations into unexplained discrepancies, and the records failed to specify conclusions or follow-ups in many cases. In addition, the facility lacked procedures for keeping potentially hazardous microorganisms out of the active drug product.