FDA Warns Beckman Coulter of Violations at Miami Facility | GenomeWeb

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has issued a warning letter to Beckman Coulter citing issues it identified at the company's Miami facility.

In a letter dated Nov. 1 and posted this week on FDA's website, the agency said that it had found that Class I and II in vitro diagnostic products manufactured at the site were "adulterated … and not in conformity with the Current Good Manufacturing Practice requirements" as defined by federal regulations.

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