PReye, LLC
FDA inspection history in Wheat Ridge, Colorado, 2026
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2026: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2026One warning letter and one Form 483, at Wheat Ridge, Colorado.
Cited most
Across all PReye observations on file
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.42Design and construction features1
The complete PReye file.
All 2 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
Wheat Ridge, Colorado
One warning letter and one Form 483 · 2026 · 4 observations
Latest: Warning letter, Aug 18, 2026 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-08-18 | Warning letter Warning letter | Wheat Ridge, Colorado | — | $99 |
| 2026-03-19 | 483 Form 483 | Wheat Ridge, Colorado | 4 | $99 |
Investigators on these documents
FEI number 3031057987 · most recent document Aug 18, 2026
About PReye, LLC
How many FDA Form 483s has PReye, LLC received?
FDA Intel has 1 Form 483 on file for PReye, LLC; the most recent is dated Mar 19, 2026.
When was PReye, LLC last inspected by FDA?
The most recent FDA inspection document on file for PReye, LLC is a Form 483 dated Mar 19, 2026, for the site in Wheat Ridge, Colorado.
What did FDA cite at PReye, LLC?
The regulations cited most in the observations on file for PReye, LLC are 21 CFR 211.165 (Testing and release for distribution), 1 time; 21 CFR 211.22 (Responsibilities of quality control unit), 1 time; 21 CFR 211.42 (Design and construction features), 1 time.
Has PReye, LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for PReye, LLC; the most recent is dated Aug 18, 2026.