483
Vevazz LLCFDA 483 - Vevazz LLC - June 20, 2019
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Record Details
Vevazz LLC, a medical device manufacturer in Eaton, CO, was inspected by the FDA from June 3-20, 2019. The inspection revealed significant deficiencies across its quality management system, with 15 observations citing a lack of established or adequately implemented procedures for critical areas. These issues indicate a systemic failure to comply with medical device quality system regulations.
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ID · 5409fa2f-3f5b-49c6-b3e9-5a657d43affc