FDA Inspection 917118 — DIEM- GP DOO
The FDA completed an inspection of DIEM- GP DOO on February 11, 2015 in Gevgelija. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 11, 2015
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Gevgelija (Macedonia)
Citations
| ID | CFR | Description |
|---|---|---|
| 1173 | 21 CFR 110.40(f) | Q.C. instrument accuracy, maintenance |
| 1331 | 21 CFR 113.100(a)(1) | Still retorts |
| 1615 | 21 CFR 110.93 | Storage/transportation of finished goods (contamination) |
| 3073 | 21 CFR 114.80(a)(2) | pH testing |
| 3857 | 21 CFR 113.60(a) | Record: visual closure examination, qualified person |
| 3872 | 21 CFR 113.60(a)(3) | Closures other than double seams and glass |
| 3877 | 21 CFR 113.60(c) | Coding - required elements |
| 4519 | 21 CFR 108.35(c)(3)(i) | Process adherence |