# FDA 483 - Nelson Laboratories, LLC - July 30, 2025

Source: https://www.keypedia.com/records/483/nelson-laboratories-llc/ac9a0bce-7b93-4e64-9ec7-55de2a23160e

> FDA 483 for Nelson Laboratories, LLC on July 30, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nelson Laboratories, LLC
- Inspection Date: 2025-07-30
- Product Type: other
- Office Name: FDA District Office — Denver, Colorado
- Summary: Nelson Laboratories, LLC received an FDA Form 483 citing multiple deficiencies in their testing and quality control processes for human cells, tissues, and cellular and tissue-based products (HCT/Ps). Observations included improper handling of amended test results, inadequate record-keeping, contamination risks during processing, and failures in environmental control and personnel training. The findings indicate a lack of robust procedures and controls to ensure product quality and prevent the spread of communicable diseases.

## Related Documents

- [EIR - 2018-03-30](https://www.keypedia.com/records/eir/nelson-laboratories-llc/a3291d5c-3e93-4f0b-9d72-dcd1985d980e)
- [483 - 2023-06-02](https://www.keypedia.com/records/483/nelson-laboratories-llc/7a634c97-116d-40a6-9b4e-d5512f292d81)
- [483 - 2025-07-30](https://www.keypedia.com/records/483/nelson-laboratories-llc/0d6e5158-7eb1-4ec2-959f-8239c84a434e)

## Related Officers

- [Emily B. Camire](https://www.keypedia.com/people/emily-b-camire/dff5f4c6-bcbe-4ef1-ac0b-1b2701b311ef)
- [Laurissa S. Flowers](https://www.keypedia.com/people/laurissa-s-flowers/27453525-c2fc-4a05-9cdc-7a1ed884304f)

Company: https://www.keypedia.com/companies/nelson-laboratories-llc/978675b0-9c60-4e40-9336-6a71b9f79805

Office: https://www.keypedia.com/offices/fda-district-office-denver-colorado/1670d160-cbfd-48fd-b9c1-fbba4631fcb0