483
Air-Tite Products Co IncFDA 483 - Air-Tite Products Co Inc - October 11, 2019
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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).
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