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Pharmaceuticals / Inspections and Audits

FDA Cites Florida Sterile Drugmaker for Various Violations

Jan. 8, 2019

Sterile drug manufacturer Horizon Pharmaceuticals found itself in the FDA’s crosshairs for violations at its Riviera Beach, Florida Facility.

During the Aug. 13-17 inspection, the agency found the facility lacked air classification specifications for its ISO 7 clean room. The room contained ISO 5 aseptic fill equipment, which requires an ISO surrounding environment, the agency noted in the Form 483.

The facility also failed to follow procedures designed to prevent contamination of its sterile drug products — for example, failing to perform smoke studies that would help determine what risks air and personnel movement during aseptic studies could pose to sterility.

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