483
Variamed, LLCFDA 483 - Variamed, LLC - December 18, 2024
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Record Details
Variamed, LLC in Chattanooga, TN, a specification developer of Class I and Class II medical devices, received a Form FDA-483 with 12 observations. The inspection revealed a severe lack of fundamental quality system procedures, including design control, purchasing, CAPA, complaint handling, medical device reporting, and unique device identification requirements. These deficiencies indicate a comprehensive failure to establish and maintain a compliant quality system.
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ID · 367f794b-7d83-4f45-80ac-8e5bf1e7f2e7