Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
Critical control points
Cited by Isaac K Carney, Joseph T Frost, Scott M Loughan, David S Firley
Corrective action plan
Cited by Isaac K Carney, Joseph T Frost, Scott M Loughan, David S Firley
Signed and dated
Cited by Isaac K Carney, Joseph T Frost, Scott M Loughan, David S Firley
Records - content
Cited by Isaac K Carney, Joseph T Frost, Scott M Loughan, David S Firley
Sanitation monitoring
Cited by Isaac K Carney, Joseph T Frost, Scott M Loughan, David S Firley
Inspected site
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 123.11(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.9(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 observations
Every observation in full, 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