483
Nexera Medical, Inc.Nexera Medical, Inc. – FDA 483, Aug 23, 2022
Record Details
Nexera Medical, Inc. in Fort Lauderdale, FL, a specification developer, received a Form FDA 483 with one repeat observation. The firm failed to adequately establish and follow procedures for quality audits, specifically not performing internal audits since 2019 despite distributing SpectraShield Antimicrobial Respirator Masks. This observation was also cited in a previous 2012 FDA inspection.
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ID · b3349cee-a874-44df-80d4-74fa103c8885
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