# FDA 483 - Airway Management, Inc - March 13, 2020

Source: https://www.globalkeysolutions.net/records/483/airway-management-inc/9d28a8d1-60ed-4da1-9d4e-c7a94c5e0900

> FDA 483 for Airway Management, Inc on March 13, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Airway Management, Inc
- Inspection Date: 2020-03-13
- Product Type: device
- Office Name: Dallas District Office
- Summary: Airway Management, Inc. in Carrollton, TX, was inspected from March 9-13, 2020, and received one observation. The inspection revealed significant deficiencies in the firm's complaint handling procedures, particularly regarding the timely processing, evaluation, and assessment of Medical Device Report (MDR) reportable events. The firm also lacked a clear definition of "serious injury" in its MDR procedure.

## Related Officers

- [Akbar J. Zaidi](https://www.globalkeysolutions.net/people/akbar-j-zaidi/9cd9ac91-2d4b-4f6f-a975-865342075924)
- [Marlo-Ian M. Alintanahin](https://www.globalkeysolutions.net/people/marlo-ian-m-alintanahin/a37da927-b369-4753-b275-41743556f25e)

Company: https://www.globalkeysolutions.net/companies/airway-management-inc/06c7ab56-ca4b-4c1e-8fc4-6a7c6f3b238c

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9