Overview
- 3 public-safe observations are available for this inspection.
- 3 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.
5 Sep 2014
21 CFR 211.28(a)
Clothing appropriate for duties performed
Cited by Margaret M Annes, Cheryl L Love Harris
5 Sep 2014
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Margaret M Annes, Cheryl L Love Harris
5 Sep 2014
21 CFR 211.84(d)(3)
Certificates of Testing (Containers, Closures)
Cited by Margaret M Annes, Cheryl L Love Harris
Inspected site
OCOrion Corporation, Orion PharmaEspoo, Finland
Inspection team
CLCheryl L Love Harris
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(3) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 3 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