FDA Inspection 818265 — Solara, Inc.
The FDA completed an inspection of Solara, Inc. on February 6, 2013 in Miami Lakes, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 6, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Miami Lakes, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15560 | 21 CFR 111.260(k)(2) | Batch record - label |
| 15602 | 21 CFR 111.160(e) | Packaging, labels - mix-ups |
| 15736 | 21 CFR 111.353 | Manufacturing operations - written procedures |
| 15828 | 21 CFR 111.70(a) | Specifications - manufacturing process |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |