# FDA 483 - Compumedics USA, Inc - March 05, 2019

Source: https://www.keypedia.com/records/483/compumedics-usa-inc/d219cb04-b894-42fb-a0a1-2d465a58f222

> FDA 483 for Compumedics USA, Inc on March 05, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Compumedics USA, Inc
- Inspection Date: 2019-03-05
- Product Type: device
- Office Name: Atlanta District Office
- Summary: This FDA Form 483 report details an inspection of Consumedics USA, Inc. in Charlotte, NC, a firm engaged in repacking and relabeling medical devices. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures for servicing, installation, calibration, CAPA, complaint handling, and incoming product acceptance. These observations indicate a broad lack of established and documented quality control processes for medical devices.

## Related Documents

- [483 - 2021-09-16](https://www.keypedia.com/records/483/compumedics-usa-inc/79a53763-e000-4a57-b0bd-8bcec8027d10)

## Related Officers

- [Gamal A. Norton](https://www.keypedia.com/people/gamal-a-norton/6b52c9e6-d579-4994-81ee-e734eb1f0a67)

Company: https://www.keypedia.com/companies/compumedics-usa-inc/08e0a6e2-e7ea-401b-9876-10e25123f57b

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7