PReye, LLC
Form 483 issued March 19, 2026 · Wheat Ridge, Colorado
- Inspection
- Mar 17 – Mar 19, 2026
- Investigator
- Brittny C. Cargo
- Observations
- 4
- Pages
- 4
- FEI number
- 3031057987
In short: On March 19, 2026, FDA issued a Form 483 with 4 observations to PReye, LLC in Wheat Ridge, Colorado (FEI 3031057987) after an inspection that ran Mar 17 – Mar 19, 2026. The investigator was Brittny C. Cargo. Most observations concern facilities & equipment and laboratory controls.
At a glance
Observations span 3 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
The identity of each component of a drug product is not verified by conducting at least…
- 04
There is no quality…
This inspection in context
Brittny C. Cargo
14 documents · 2022–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Louisiana.
The firmPReye, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PReye, LLC?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected PReye, LLC?
Brittny C. Cargo is named on this Form 483, for the inspection of Mar 17 – Mar 19, 2026. Each investigator has a profile showing what they cite most.
When was PReye, LLC inspected by FDA?
The inspection ran Mar 17 – Mar 19, 2026, and the Form 483 is dated March 19, 2026.
How do I get the full Form 483 for PReye, 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.