Overview
- 6 public-safe observations are available for this inspection.
- 6 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
28 Jun 2012
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Daniel P Stlaurent
28 Jun 2012
21 CFR 606.100(b)(12)
Criteria for suitability of reissue of returned blood
Cited by Daniel P Stlaurent
28 Jun 2012
21 CFR 606.160(a)(1)
Person performing, test results, interpretation
Cited by Daniel P Stlaurent
Inspected site
PLPresbyterian/St. Luke's Medical Center Donor ServicesDenver, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.194(a)(8) | 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)(12) | 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 640.2(c)(3) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 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