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Pharmaceuticals / Inspections and Audits

FDA Hits Connecticut Sterile Drugmaker for Mold Contamination

Jan. 3, 2019

The FDA cited Johnson Memorial Cancer Center’s Enfield, Connecticut sterile drug manufacturing facility after investigators found sterility problems, airflow issues and mold contamination during an Oct. 1 to Oct. 19 inspection.

The investigators found contamination in ISO 5 aseptic processing areas that the firm failed to properly investigate, including mold in a biological safety cabinet and laminar air flow hood, and colonies of Bacillus cereus in a laminar air flow hood.

The agency officials also found contamination in ISO 7 classified areas that were adjacent to aseptic processing areas. For example, numerous mold colonies were discovered in anterooms, an anteroom sink and non-hazardous drug buffer rooms.

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