Promedtek, Inc.March 22, 2023

FDA 483 - Promedtek, Inc. - March 22, 2023

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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.

Company: Promedtek, Inc.
Inspection Date: March 22, 2023
Product Type: Device
Office: Division of Pharmaceutical Quality Operations IV
Person: Charles L. Larson (investigator)

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ID · 9107871d-2fcf-4af0-9e98-f78f256c6e09