The FDA cited Milbar Laboratories, an OTC drug manufacturer based in East Haven, Connecticut, for repeat inspection observations including failure to sterilize a purified water system.
In a review of water sampling logs from May 2016 to December 2017, the FDA investigator found only intermittent water sampling, according to the Form 483.
The purified water system was not on a preventive maintenance schedule and was only serviced by an outside source when its red light illuminated. In addition, a water sample failure was recorded in an OOS investigation but the firm did not carry out a risk assessment.
The investigator also observed the firm’s failure to properly handle OOS results. For example, it did not perform an investigation of OOS results for its Essential Skin Protection OTC product. Another OOS involved a manufacturing failure that was not investigated and corrective actions were not taken.
The investigator also observed a lack of process validation for an OTC drug product — a nonconformance previously seen in 2013 and 2016 inspections. The firm failed to complete process validation for 24 of 28 marketed OTC drug product formulations and failed to perform cleaning validations for most of the formulation.
In addition, the firm’s master batch records for OTC drug products lacked complete manufacturing instructions. For instance, the firm’s process validation protocol did not include clear instructions for mixing times and was it different from the mixing time listed in the master batch record for the same formulation.
The firm also released batch records to manufacturing without oversight from its quality unit, and the unit lacked key staff members. The quality unit was being run by the chief operations officer at the time of the inspection.