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Pharmaceuticals / Inspections and Audits

FDA Hits Connecticut Sterile Drugmaker for Mold Contamination

Jan. 3, 2019
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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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