# FDA 483 - Tech Medical Services, Inc - September 19, 2023

Source: https://www.keypedia.com/records/483/tech-medical-services-inc/588f5d60-622e-48ac-8124-954ed2c868b3

> FDA 483 for Tech Medical Services, Inc on September 19, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tech Medical Services, Inc
- Inspection Date: 2023-09-19
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Tech Medical Services, Inc. in Nixa, MO, a repackager/relabeler of medical devices, received a Form FDA 483 with five observations during an inspection from September 18-19, 2023. The observations primarily concern deficiencies in the firm's quality system, including inadequate procedures for supplier control, finished device acceptance, employee training, management review, and quality audits. These issues indicate a lack of established and maintained quality system processes, specifically impacting Class II sterile probe covers.

## Related Officers

- [Eric C. Fox](https://www.keypedia.com/people/eric-c-fox/218af117-1551-476f-80ba-172e2cd6baee)

Company: https://www.keypedia.com/companies/tech-medical-services-inc/94b1ddb4-6121-4d5d-b2b8-f6076c751cb0

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8