Overview
- 8 public-safe observations are available for this inspection.
- 8 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.
10 Oct 2014
21 CFR 803.50(b)(2)
Explanation of Incomplete Information
Cited by Jesse A Vazquez, Audrey A De La Cruz, Audrey De La Cruz
10 Oct 2014
21 CFR 820.20(b)
Lack of or inadequate organizational structure
Cited by Jesse A Vazquez, Audrey A De La Cruz, Audrey De La Cruz
10 Oct 2014
21 CFR 820.22
Quality Audit/Reaudit - conducted
Cited by Jesse A Vazquez, Audrey A De La Cruz, Audrey De La Cruz
10 Oct 2014
21 CFR 820.25(b)
Training - Lack of or inadequate procedures
Cited by Jesse A Vazquez, Audrey A De La Cruz, Audrey De La Cruz
10 Oct 2014
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Jesse A Vazquez, Audrey A De La Cruz, Audrey De La Cruz
Inspected site
RWRichard Wolf Medical Instruments Corp.Vernon Hills, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.50(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(3) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 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