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.
2 Jul 2009
21 CFR 606.60(a)
Equipment observed, standardized, calibrated
Cited by Devon M Shoop, Kathryn A Krentz
2 Jul 2009
21 CFR 606.160(a)(1)
Person performing, test results, interpretation
Cited by Devon M Shoop, Kathryn A Krentz
2 Jul 2009
21 CFR 1271.160(c)
Quality audits performed periodically
Cited by Devon M Shoop, Kathryn A Krentz
2 Jul 2009
21 CFR 1271.200(a)
Cleaned, sanitized per established schedules
Cited by Devon M Shoop, Kathryn A Krentz
Inspected site
OHOregon Health & Science UniversityPortland, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.160(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.200(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.60(a) | 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