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

Source: https://www.keypedia.com/records/483/air-tite-products-co-inc/c9ebedd3-b39a-49f9-944d-215fdfbb138f

> FDA 483 for Air-Tite Products Co Inc on October 11, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Air-Tite Products Co Inc
- Inspection Date: 2019-10-11
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: 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).

## Related Officers

- [Wilfred A. Darang](https://www.keypedia.com/people/wilfred-a-darang/f0f1e653-891d-47d6-82e3-5ce40a5d3635)

Company: https://www.keypedia.com/companies/air-tite-products-co-inc/c62e3fba-0fe9-4290-b5c8-61a04168cd1f

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e