FDA Inspection 1103187 — Myllan-ORA Ehf
The FDA completed an inspection of Myllan-ORA Ehf on Sep 13, 2019 in Kopavogur. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 13, 2019
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Kopavogur (Iceland)
Citations
| ID | CFR | Description |
|---|---|---|
| 1316 | 21 CFR 113.87(c) | Initial temperature of container contents |
| 16490 | 21 CFR 113.40(j) | Other systems: Commercial sterility |
| 3877 | 21 CFR 113.60(c) | Coding - required elements |
| 4519 | 21 CFR 108.35(c)(3)(i) | Process adherence |
| 4524 | 21 CFR 108.35(g) | Approved school |