FDA Inspection 894155 — SILICIUM ESPANA LABORATORIOS SL
The FDA completed an inspection of SILICIUM ESPANA LABORATORIOS SL on July 15, 2014 in Vila-Seca. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 15, 2014
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Vila-Seca (Spain)
Citations
| ID | CFR | Description |
|---|---|---|
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15812 | 21 CFR 111.570(b)(2)(ii)(A) | Record - product complaint; name, description |
| 15813 | 21 CFR 111.570(b)(2)(ii)(B) | Record - product complaint; batch, lot, control number |
| 15817 | 21 CFR 111.570(b)(2)(ii)(F) | Record - product complaint; findings |
| 16058 | 21 CFR 111.535(b)(2) | Records - ret'nd dietary supplement: material review, dispos |