483
Promedtek, Inc.FDA 483 - Promedtek, Inc. - March 22, 2023
Record Details
Promedtek, Inc. in Scottsdale, AZ, a specification developer, was inspected by the FDA, resulting in two observations. The inspection revealed deficiencies in establishing procedures for finished device acceptance, specifically regarding output specification testing. Additionally, the firm failed to include required details in its complaint investigation records for multiple confirmed and applicator-related issues.
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ID · 9107871d-2fcf-4af0-9e98-f78f256c6e09