Overview
- 5 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
29 May 2009
21 CFR 600.10(b)
Personnel capabilities
Cited by Michael S Kopf, Melinda L Rice, Richard L Rutherford
29 May 2009
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Michael S Kopf, Melinda L Rice, Richard L Rutherford
29 May 2009
21 CFR 606.160(b)
Required records
Cited by Michael S Kopf, Melinda L Rice, Richard L Rutherford
29 May 2009
21 CFR 640.63(a)
Determining donor suitability
Cited by Michael S Kopf, Melinda L Rice, Richard L Rutherford
Inspected site
OPOctapharma Plasma, Inc.Wichita, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 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 606.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 640.63(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 640.65(b)(8) | 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