Warning Letter Roundup & Recap – 27 February 2020
In separate warning letters, the US FDA says Biomedix (a maker of I.V. administration sets) and Unetixs Vascular (a maker of vascular diagnostic ultrasound systems) must hire outside consultants to review their quality systems after serious deficiencies were noted by agency investigators. A total of three enforcement missives were released by the FDA this week.
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