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Connecticut Drugmaker Flagged for Repeat Violations
Drugs Inspections and Audits
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.