Air-Tite Products Co IncOctober 11, 2019

FDA 483 - Air-Tite Products Co Inc - October 11, 2019

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Record Details

An FDA inspection of Air-tite Products Co Inc in Virginia Beach, VA, a manufacturer, revealed two significant observations. The firm failed to adequately establish procedures for complaint handling, specifically regarding the evaluation of complaints for Medical Device Reporting (MDR) reportability. Additionally, the company had not adequately established procedures for corrective and preventive actions (CAPA).

Company: Air-Tite Products Co Inc
Inspection Date: October 11, 2019
Product Type: Device
Office: Division of Human and Animal Food Operations - East II
Person: Wilfred A. Darang

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ID · c9ebedd3-b39a-49f9-944d-215fdfbb138f