Overview
- 4 public-safe observations are available for this inspection.
- 3 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.
17 Aug 2009
21 CFR 820.80(d)(3)
No release signature
Cited by Cynthia A Harris, Nebil A Oumer, Jesse P Hardin
17 Aug 2009
21 CFR 820.181(b)
DMR production process specifications
Cited by Cynthia A Harris, Nebil A Oumer, Jesse P Hardin
17 Aug 2009
21 CFR 820.198(a)
Complete files maintained
Cited by Cynthia A Harris, Nebil A Oumer, Jesse P Hardin
Inspected site
RMRebuilder Medical, Inc.Charles Town, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.181(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d)(3) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 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