Overview
- 9 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.
19 Mar 2015
21 CFR 600.12(a)
Maintenance - concurrence
Cited by Brandy D Brown, Leslie W Gilbert, Brandy Davis Brown
19 Mar 2015
21 CFR 606.100(b)
Maintained and followed
Cited by Brandy D Brown, Leslie W Gilbert, Brandy Davis Brown
19 Mar 2015
21 CFR 606.100(c)
Thorough investigations
Cited by Brandy D Brown, Leslie W Gilbert, Brandy Davis Brown
19 Mar 2015
21 CFR 606.165(a)
Distribution and receipt - recalls
Cited by Brandy D Brown, Leslie W Gilbert, Brandy Davis Brown
19 Mar 2015
21 CFR 606.20(b)
Qualifications of responsible personnel
Cited by Brandy D Brown, Leslie W Gilbert, Brandy Davis Brown
Inspected site
TAThe American National Red Cross - Southern RegionDouglasville, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 600.12(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 610.53(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 610.53(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 640.34(g)(1) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 9 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