Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
7 Oct 2010
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Janae D Price, Debra Boyd Seale
7 Oct 2010
21 CFR 606.160(a)(2)
Determination of lot numbers and supplies
Cited by Janae D Price, Debra Boyd Seale
7 Oct 2010
21 CFR 610.47
Notification of transfusion recipients
Cited by Janae D Price, Debra Boyd Seale
7 Oct 2010
21 CFR 640.3(a)(1)
Donor suitability procedures not followed
Cited by Janae D Price, Debra Boyd Seale
Inspected site
EHEdward Hospital Blood BankNaperville, 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 | 1x |
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 610.47 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 640.3(a)(1) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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