FDA Inspection 962630 — Pralus Sas
The FDA completed an inspection of Pralus Sas on February 16, 2016 in Roanne. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 16, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Roanne (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 1126 | 21 CFR 110.40(a) | Precluding contaminants |
| 1173 | 21 CFR 110.40(f) | Q.C. instrument accuracy, maintenance |
| 1292 | 21 CFR 110.20(b)(1) | Sufficient space |
| 1306 | 21 CFR 110.20(b)(7) | Screening |
| 1403 | 21 CFR 110.10(b)(4) | Hand jewelry - remove/cover |
| 1406 | 21 CFR 110.10(b)(6) | Effective use of hair restraint |
| 1581 | 21 CFR 110.37(e) | Running water at suitable temperature |
| 1670 | 21 CFR 110.80(a)(4) | Safety assurance - pests/extraneous materials |
| 1702 | 21 CFR 110.80(b)(8) | Metal / extraneous materials |
| 1709 | 21 CFR 110.80(b)(13) | Filling, assembling, packing controls |
| 3661 | 21 CFR 110.37(e)(5) | Signs |