Overview
- 4 public-safe observations are available for this inspection.
- 4 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.
6 Feb 2014
21 CFR 606.20(b)
Qualifications of responsible personnel
Cited by Karen M Montgomery, Kathleen B Swat
6 Feb 2014
21 CFR 606.100(b)(13)
Procedures to relate blood from donor to final disposition
Cited by Karen M Montgomery, Kathleen B Swat
6 Feb 2014
21 CFR 606.171
Biological product deviation report
Cited by Karen M Montgomery, Kathleen B Swat
Inspected site
BHBarnes-Jewish Hospital Blood BankSaint Louis, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(b)(13) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.171 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 640.25(b)(4) | 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