# FDA 483 - Seacole-CRC, LLC - February 13, 2026

Source: https://www.globalkeysolutions.net/records/483/seacole-crc-llc/6d601161-e771-4f4c-a267-a209cadb81b0

> FDA 483 for Seacole-CRC, LLC on February 13, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Seacole-CRC, LLC
- Inspection Date: 2026-02-13
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Seacole-CRC, LLC in Plymouth, MN, revealed significant deficiencies in their quality management system and process validation. The firm failed to maintain adequate documentation for risk management, design transfer, sample testing, supplier control, and design changes. Additionally, procedures for validating manufacturing processes, including cleaning and liquid blending for medical devices, were not documented.

## Related Officers

- [Alicia U. Jacobo](https://www.globalkeysolutions.net/people/alicia-u-jacobo/5f75a995-c0df-4615-be88-d401df48ad26)

Company: https://www.globalkeysolutions.net/companies/seacole-crc-llc/1a2bbed3-f198-4b0e-bcb6-7678fb7bbdad

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d