North American Custom Laboratories, LLC
Form 483 issued September 5, 2025 · Richardson, Texas
- Inspection
- Aug 25 – Sep 5, 2025
- Investigator
- Demario L. Walls
- Observations
- 1
- Pages
- 3
- FEI number
- 3014229024
In short: On September 5, 2025, FDA issued a Form 483 with 1 observation to North American Custom Laboratories, LLC in Richardson, Texas (FEI 3014229024) after an inspection that ran Aug 25 – Sep 5, 2025. The investigator was Demario L. Walls.
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
Production areas have difficult to clean or contain porous, particle generating, or visibly…
This inspection in context
Demario L. Walls
18 documents · 2020–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmNorth American Custom Laboratories, LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
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Questions about this 483
What did FDA find at North American Custom Laboratories, LLC?
FDA listed 1 observation on this Form 483. The opening words of each observation are shown on this page.
Who inspected North American Custom Laboratories, LLC?
Demario L. Walls is named on this Form 483, for the inspection of Aug 25 – Sep 5, 2025. Each investigator has a profile showing what they cite most.
When was North American Custom Laboratories, LLC inspected by FDA?
The inspection ran Aug 25 – Sep 5, 2025, and the Form 483 is dated September 5, 2025.
How do I get the full Form 483 for North American Custom Laboratories, 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.