FDA Warning Letter Recap, October 2021: Maker Of Blood Collection Device Cited For Quality System Violations
The warning letter to the Seattle-based company was the product of six-week in-person inspection that stretched from June to July. A total of five device-related missives were released by the US agency last month.
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Invacare, Smiths Medical and CellEra were cited for quality systems and Medical Device Reporting violations in the only device-related warning letters released by the agency last month.
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