FDA Inspection 1103187 — Myllan-ORA ehf
The FDA completed an inspection of Myllan-ORA ehf on September 13, 2019 in Kopavogur. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- September 13, 2019
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- 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 |