Overview
- 7 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
12 Jun 2012
21 CFR 113.40(g)(2)(i)(A)
Recording device - flow rate, temperature, concentration
Cited by Brian R Yaun
Inspected site
WOWWF Operating Company LLCMount Crawford, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 113.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 113.60(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.80(b)(13) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.40(g)(2)(i)(A) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.89 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 7 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