FDA Inspection 1170583 — Myllan-ORA ehf
The FDA completed an inspection of Myllan-ORA ehf on May 25, 2022 in Kopavogur. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 25, 2022
- Fiscal Year
- 2022
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Kopavogur (Iceland)
Citations
| ID | CFR | Description |
|---|---|---|
| 1524 | 21 CFR 123.11(b) | Sanitation monitoring |
| 6004 | 21 CFR 123.6(c)(4) | Monitoring - adequacy |
| 960 | 21 CFR 123.6(c)(2) | Critical control points |
| 963 | 21 CFR 123.6(c)(5) | Corrective action plan |