FDA Inspection 910768 — Orion Corporation, Orion Pharma
The FDA completed an inspection of Orion Corporation, Orion Pharma on September 5, 2014 in Espoo. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- September 5, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Espoo (Finland)
Citations
| ID | CFR | Description |
|---|---|---|
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 4317 | 21 CFR 211.84(d)(3) | Certificates of Testing (Containers, Closures) |