FDA Inspection 825746 — Eau Zone Huiles & Fragrances Lee
The FDA completed an inspection of Eau Zone Huiles & Fragrances Lee on Dec 20, 2012 in Montreal. 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). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 20, 2012
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Montreal (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 4377 | 21 CFR 211.188(b)(3) | Identification of each component or in-process material |
| 4378 | 21 CFR 211.188(b)(2) | Identity of major equipment and lines used |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4576 | 21 CFR 211.192 | No written record of investigation |