# FDA 483 - Atlas Medical Holdings Inc - September 21, 2023

Source: https://www.globalkeysolutions.net/records/483/atlas-medical-holdings-inc/abdc4256-81fd-4765-8e68-c3d07567d7b7

> FDA 483 for Atlas Medical Holdings Inc on September 21, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Atlas Medical Holdings Inc
- Inspection Date: 2023-09-21
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Atlas Medical Holdings Inc, a storage distributor in San Antonio, TX, was inspected regarding its handling of HCT/Ps. The inspection revealed significant deficiencies, including a lack of documented inspection for incoming HCT/Ps like OcuGraft, and the absence of a comprehensive quality program to address core current good tissue practice (CGTP) requirements. These issues indicate a failure to ensure product quality and prevent the spread of communicable diseases.

## Related Officers

- [Bobbi Miller](https://www.globalkeysolutions.net/people/bobbi-miller/60517ce9-0fee-4099-98ef-c7329af0518a)
- [investigator](https://www.globalkeysolutions.net/people/robert-m-tillman/091c720a-1240-468f-8b05-2b3f6f5a14bd)

Company: https://www.globalkeysolutions.net/companies/atlas-medical-holdings-inc/555edfda-acae-434c-b3ea-eea167601554

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab