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Pharmaceuticals / Inspections and Audits

FDA Cites Florida OTC Drugmaker for Contamination Risks

Jan. 28, 2019
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The FDA flagged OTC drugmaker Laboratorios Quantium over conditions at its Medley, Florida facility.

During an inspection conducted between May and August 2018, the investigator noted multiple potential hazards, including standing water in the hoses of a filling machine that had been declared clean. The firm’s office manager said the water was kept there to prevent cracks until the next scheduled manufacturing batch.

The investigator also observed what appeared to be white residue and brown standing liquid inside a filling machine’s holding tank, which was supposed to be clean. The bottom of the stainless steel mixing tank also had brown stains — despite being identified as clean — and a peeling black seal around the inside lid.

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