Overview
- 7 public-safe observations are available for this inspection.
- 7 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.
24 Oct 2025
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Michael T Cyrus, Inga M Warr, Brittny C Cargo, Rodney L Tinzie
24 Oct 2025
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Michael T Cyrus, Inga M Warr, Brittny C Cargo, Rodney L Tinzie
24 Oct 2025
21 CFR 211.188(b)
Batch production and Batch Control Record Requirements
Cited by Michael T Cyrus, Inga M Warr, Brittny C Cargo, Rodney L Tinzie
24 Oct 2025
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Michael T Cyrus, Inga M Warr, Brittny C Cargo, Rodney L Tinzie
24 Oct 2025
21 CFR 211.56(a)
Sanitation--buildings not clean, free of infestation
Cited by Michael T Cyrus, Inga M Warr, Brittny C Cargo, Rodney L Tinzie
Inspected site
C2CareFusion 213, LLCEl Paso, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(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 7 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