FDA Inspection 1007005 — Wilbo S.A.
The FDA completed an inspection of Wilbo S.A. on March 7, 2017 in Gdynia. 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
- March 7, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Gdynia (Poland)
Citations
| ID | CFR | Description |
|---|---|---|
| 1316 | 21 CFR 113.87(c) | Initial temperature of container contents |
| 16352 | 21 CFR 113.40(b)(2)(iv) | Still water retorts:Recorder-controller sensor:heating media |
| 2149 | 21 CFR 113.40(b)(1)(v) | TID not reference instrument |
| 4069 | 21 CFR 113.40(b)(14) | Heat distribution data, other retort installation |
| 4517 | 21 CFR 108.35(c)(2)(ii) | Process change substantiation |
| 4519 | 21 CFR 108.35(c)(3)(i) | Process adherence |
| 906 | 21 CFR 123.6(b) | HACCP plan location |
| 959 | 21 CFR 123.6(c)(1) | Food safety hazards |