FDA Inspection 769459 — Alberto De Miguel S.A.
The FDA completed an inspection of Alberto De Miguel S.A. on February 28, 2012 in Autol. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 28, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Autol (Spain)
Citations
| ID | CFR | Description |
|---|---|---|
| 1316 | 21 CFR 113.87(c) | Initial temperature of container contents |
| 1330 | 21 CFR 113.100(a) | Process records - forms missing information |
| 1524 | 21 CFR 123.11(b) | Sanitation monitoring |
| 2888 | 21 CFR 113.40(j) | Critical factors - frequency measured, recorded |
| 3877 | 21 CFR 113.60(c) | Coding - required elements |
| 4517 | 21 CFR 108.35(c)(2)(ii) | Process change substantiation |
| 960 | 21 CFR 123.6(c)(2) | Critical control points |