Overview
- 8 public-safe observations are available for this inspection.
- 8 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.
15 Mar 2011
21 CFR 211.68(b)
Written record not kept of program and validation data
Cited by Kathleen B Swat, Thuy T Nguyen, James D Planchon, Jeffery L Sumter
15 Mar 2011
21 CFR 600.10(b)
Personnel capabilities
Cited by Kathleen B Swat, Thuy T Nguyen, James D Planchon, Jeffery L Sumter
15 Mar 2011
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Kathleen B Swat, Thuy T Nguyen, James D Planchon, Jeffery L Sumter
15 Mar 2011
21 CFR 606.100(b)(13)
Procedures to relate blood from donor to final disposition
Cited by Kathleen B Swat, Thuy T Nguyen, James D Planchon, Jeffery L Sumter
15 Mar 2011
21 CFR 606.100(c)
Thorough investigations
Cited by Kathleen B Swat, Thuy T Nguyen, James D Planchon, Jeffery L Sumter
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 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 600.10(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(b)(13) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.171 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 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