Overview
- 6 public-safe observations are available for this inspection.
- 6 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
14 Feb 2011
21 CFR 820.22
Quality audits - Lack of or inadequate procedures
Cited by Joshua J Silvestri, Jennifer A Robinson
14 Feb 2011
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Joshua J Silvestri, Jennifer A Robinson
14 Feb 2011
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Joshua J Silvestri, Jennifer A Robinson
14 Feb 2011
21 CFR 820.181
DMR - not or inadequately maintained
Cited by Joshua J Silvestri, Jennifer A Robinson
Inspected site
AMARJ Medical, Inc.Oldsmar, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(j) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 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