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Tetracore Hit for Inadequate Quality Reviews

April 29, 2020

The FDA cited Tetracore for quality failures observed in an inspection of the firm’s Rockville, Md., facility.

The investigators found no evidence that management had reviewed the suitability and effectiveness of the company’s quality system since 2013.

The company, which develops diagnostic reagents, assays and instruments to detect infectious diseases, had manufactured equipment that was not inspected or tested often enough to ensure compliance, the agency said.

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