Amerx Healthcare CorpMarch 3, 2020

FDA 483 - Amerx Healthcare Corp - March 03, 2020

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Record Details

Amerx Healthcare Corp, a medical device kit assembler/warehouse in Clearwater, FL, was cited for three significant quality system deficiencies during an FDA inspection. These issues include a failure to implement written Medical Device Reporting (MDR) procedures and report adverse events, inadequately established quality audit procedures, and unmaintained document control procedures related to management reviews.

Company: Amerx Healthcare Corp
Inspection Date: March 3, 2020
Product Type: Device
Office: Office of Medical Device and Radiological Health Division II
Person: Stanley B. Eugene (investigator)

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ID · 17890f54-86e2-43b0-8512-1c41d6e607f1