Seacole-CRC, LLC
Form 483 issued February 13, 2026 · Plymouth, Minnesota
- Inspection
- Feb 10 – Feb 13, 2026
- Investigator
- Alicia U. Jacobo
- Observations
- 2
- Pages
- 5
- FEI number
- 3008363932
In short: On February 13, 2026, FDA issued a Form 483 with 2 observations to Seacole-CRC, LLC in Plymouth, Minnesota (FEI 3008363932) after an inspection that ran Feb 10 – Feb 13, 2026. The investigator was Alicia U. Jacobo. The most-cited regulation is 21 CFR 4.1 (what is the scope of this subpart?).
What FDA observed
Preview: the opening words of each observation- 01ISO 13485:2016 Clause 4.1.1
The quality management system was not documented in accordance…
- 02ISO 13485:2016 Clause 7.5.6
Procedures for validation of…
This inspection in context
Alicia U. Jacobo
4 documents · 2024–2026
Cites 803.17 (what are the requirements for developing, maintaining, and implementing written mdr procedures that apply to me?) more than any other section. Most of their documents are for sites in Minnesota.
The firmSeacole-CRC, LLC history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at Seacole-CRC, LLC?
FDA listed 2 observations on this Form 483. The most-cited regulation is 21 CFR 4.1 (what is the scope of this subpart?). The opening words of each observation are shown on this page.
Who inspected Seacole-CRC, LLC?
Alicia U. Jacobo is named on this Form 483, for the inspection of Feb 10 – Feb 13, 2026. Each investigator has a profile showing what they cite most.
When was Seacole-CRC, LLC inspected by FDA?
The inspection ran Feb 10 – Feb 13, 2026, and the Form 483 is dated February 13, 2026.
How do I get the full Form 483 for Seacole-CRC, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.