# FDA 483 - ARUP Laboratories, Inc. - November 06, 2024

Source: https://www.keypedia.com/records/483/arup-laboratories-inc/98c38b26-b32e-4c74-b7b0-5960d79f1872

> FDA 483 for ARUP Laboratories, Inc. on November 06, 2024. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: ARUP Laboratories, Inc.
- Inspection Date: 2024-11-06
- Product Type: biologics
- Office Name: Denver District Office
- Summary: ARUP Laboratories, Inc. in Sandy, UT, a blood bank, was issued a Form 483 following an FDA inspection that identified significant deficiencies. The firm failed to adequately test a new system, leading to critical errors such as donors incorrectly registering for platelets and an employee having unauthorized permissions to process donations. These issues indicate a lack of robust system validation and quality control impacting donor management and donation integrity.

## Related Officers

- [FDA_PERSONNEL](https://www.keypedia.com/people/deepa-e-vadakkan/89c0e1c7-4f9e-4668-81a8-e5a9ab6a0e34)
- [Emily B. Camire](https://www.keypedia.com/people/emily-b-camire/dff5f4c6-bcbe-4ef1-ac0b-1b2701b311ef)

Company: https://www.keypedia.com/companies/arup-laboratories-inc/6b8ebece-8a7c-492d-9cb5-577429c8871b

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face