Overview
- 16 public-safe observations are available for this inspection.
- 15 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.
21 Sep 2009
21 CFR 110.10(b)(3)
Not washed/sanitized when appropriate
Cited by Cecelia G Vincent, Tracey L Siebesma, Lisa M Thursam
21 Sep 2009
21 CFR 110.10(b)(6)
Effective use of hair restraint
Cited by Cecelia G Vincent, Tracey L Siebesma, Lisa M Thursam
21 Sep 2009
21 CFR 110.10(b)(7)
Storage of personal items
Cited by Cecelia G Vincent, Tracey L Siebesma, Lisa M Thursam
21 Sep 2009
21 CFR 110.10(c)
Training of handlers and supervisors
Cited by Cecelia G Vincent, Tracey L Siebesma, Lisa M Thursam
21 Sep 2009
21 CFR 110.20(b)(4)
Floors, walls and ceilings
Cited by Cecelia G Vincent, Tracey L Siebesma, Lisa M Thursam
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 110.35(a) | Cited across public-safe Form 483 observations | 2x |
| 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 110.10(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.10(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(d)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.40(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.40(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 16 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