Overview
- 5 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
Determination need for investigation
Cited by Camerson E Moore, Demario L Walls, Brittny C Cargo
Written QA procedures established, followed
Cited by Camerson E Moore, Demario L Walls, Brittny C Cargo
Orderly handling, prevention of mix-ups, prevention of contamination
Cited by Camerson E Moore, Demario L Walls, Brittny C Cargo
Written procedures for control of components, containers, and closures
Cited by Camerson E Moore, Demario L Walls, Brittny C Cargo
Adequate controls (general)
Cited by Camerson E Moore, Demario L Walls, Brittny C Cargo
Inspected site
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 212.20(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.20(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.30(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.50 | Cited across public-safe Form 483 observations | 1x |
Source document
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 5 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