Overview
- 6 public-safe observations are available for this inspection.
- 6 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
2 Oct 2025
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Ronda R Loyd Jones, Mercedes N Overton, Stephon D Tillis, Jeffrey T Prosterman
2 Oct 2025
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Ronda R Loyd Jones, Mercedes N Overton, Stephon D Tillis, Jeffrey T Prosterman
2 Oct 2025
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Ronda R Loyd Jones, Mercedes N Overton, Stephon D Tillis, Jeffrey T Prosterman
2 Oct 2025
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Ronda R Loyd Jones, Mercedes N Overton, Stephon D Tillis, Jeffrey T Prosterman
2 Oct 2025
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Ronda R Loyd Jones, Mercedes N Overton, Stephon D Tillis, Jeffrey T Prosterman
Inspected site
OIOraLabs, IncorporatedParker, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 6 observations
The source PDF, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere