North American Custom Laboratories, LLC
FDA inspection history in Richardson, Texas, 2022 to 2025
- 2
- Form 483s
- 1
- Warning letter
- 1
- Close-out
Every document, by year
- Form 483
- Warning letter
- Close-out
2022: one warning letter and one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022One warning letter and one Form 483, at Richardson, Texas.
- 2022The longest 483 on file: 8 observations over 7 pages at Richardson, Texas.
- 2025One Form 483, at Richardson, Texas.
Cited most
Across all North American Custom Laboratories observations on file
- FDCA 501(a)(2)(A)Insanitary conditions7
- 21 CFR 211.113Control of microbiological contamination2
The complete North American Custom Laboratories file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Richardson, Texas
Two Form 483s, one warning letter and one close-out letter · 2022 to 2025 · 9 observations
Latest: Form 483, Sep 5, 2025 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-09-05 | 483 Form 483 | Richardson, Texas | 1 | $99 |
| 2022-11-18 | Warning letter Warning letter | Richardson, Texas | — | $99 |
| 2022-03-10 | 483 Form 483 | Richardson, Texas | 8 | $99 |
| Undated | Close-out Close-out letter | Richardson, Texas | — | $99 |
Investigators on these documents
FEI number 3014229024 · most recent document Sep 5, 2025
About North American Custom Laboratories, LLC
How many FDA Form 483s has North American Custom Laboratories, LLC received?
FDA Intel has 2 Form 483s on file for North American Custom Laboratories, LLC; the most recent is dated Sep 5, 2025.
When was North American Custom Laboratories, LLC last inspected by FDA?
The most recent FDA inspection document on file for North American Custom Laboratories, LLC is a Form 483 dated Sep 5, 2025, for the site in Richardson, Texas.
What did FDA cite at North American Custom Laboratories, LLC?
The regulations cited most in the observations on file for North American Custom Laboratories, LLC are FDCA 501(a)(2)(A) (Insanitary conditions), 7 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times.
Has North American Custom Laboratories, LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for North American Custom Laboratories, LLC; the most recent is dated Nov 18, 2022.