Overview
- 4 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
21 Jun 2013
21 CFR 211.68(b)
input/output verification
Cited by Brandy D Brown, Leslie W Gilbert, Cordelia J Brammer, Kimberly C Delk-Brooks
21 Jun 2013
21 CFR 211.103
Yield calculations not verified by 2nd person
Cited by Brandy D Brown, Leslie W Gilbert, Cordelia J Brammer, Kimberly C Delk-Brooks
21 Jun 2013
21 CFR 606.65(e)
Following manufacturer's instructions
Cited by Brandy D Brown, Leslie W Gilbert, Cordelia J Brammer, Kimberly C Delk-Brooks
21 Jun 2013
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Brandy D Brown, Leslie W Gilbert, Cordelia J Brammer, Kimberly C Delk-Brooks
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 211.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.65(e) | 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