Washington Drugmaker Cited for Lacking Quality Unit
The FDA hit OTC drug manufacturer NeoBiotech Global of Auburn, Washington with a Form 483 for operating without a quality control unit and other serious violations.
An agency inspection of the facility found that the drugmaker had no organization or individual designated as a quality unit and no one at the firm was responsible for approving or rejecting products. It also lacked procedures for approving product changes.
The investigator also flagged the absence of written procedures for handling and documenting complaints and for documenting how raw materials and containers for drug products were received, stored and handled.