# FDA 483 - Donor Services Laboratory, Inc. Las Vegas - April 12, 2024

Source: https://www.globalkeysolutions.net/records/483/donor-services-laboratory-inc-las-vegas/a719abee-2ff5-4d41-b160-62defa75fb83

> FDA 483 for Donor Services Laboratory, Inc. Las Vegas on April 12, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Donor Services Laboratory, Inc. Las Vegas
- Inspection Date: 2024-04-12
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Donor Services Laboratory, Inc. Las Vegas, a RCDAD Testing Laboratory, revealed significant issues across its operations. The firm failed to adhere to manufacturer's instructions for communicable disease testing, did not adequately verify computer software performance, and used unvalidated testing equipment. Additionally, deficiencies were noted in record-keeping, the quality program's handling of deviations, and the maintenance of test kit lot documentation.

## Related Officers

- [Emily B. Camire](https://www.globalkeysolutions.net/people/emily-b-camire/dff5f4c6-bcbe-4ef1-ac0b-1b2701b311ef)
- [investigator](https://www.globalkeysolutions.net/people/kaarin-m-slotte/2960bbe1-17ba-4295-9aa8-2514a1595336)

Company: https://www.globalkeysolutions.net/companies/donor-services-laboratory-inc-las-vegas/b5e897f3-2297-443e-9278-ffba4daffbd8

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b