Overview
- 11 public-safe observations are available for this inspection.
- 11 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.
29 Nov 2011
21 CFR 110.10(b)(3)
Not washed/sanitized when appropriate
Cited by Jeffrey D Meng, Margaret N Persich, Vesa Vuniqi
29 Nov 2011
21 CFR 110.10(b)(6)
Failure to wear
Cited by Jeffrey D Meng, Margaret N Persich, Vesa Vuniqi
29 Nov 2011
21 CFR 110.35(a)
Buildings/good repair
Cited by Jeffrey D Meng, Margaret N Persich, Vesa Vuniqi
29 Nov 2011
21 CFR 110.35(d)
Failure to clean - general
Cited by Jeffrey D Meng, Margaret N Persich, Vesa Vuniqi
29 Nov 2011
21 CFR 110.37(b)(1)
Sufficient quantities of water
Cited by Jeffrey D Meng, Margaret N Persich, Vesa Vuniqi
Inspected site
GHGreen Hope LLC dba Rosewood ProductsAnn Arbor, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.10(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.10(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.40(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(6) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 11 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