FDA Inspection 1074459 — Refresqueria Estrella Inc.
The FDA completed an inspection of Refresqueria Estrella Inc. on December 13, 2018 in Bayamon, PR. 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
- December 13, 2018
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Bayamon, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18138 | 21 CFR 117.10 | Personnel |
| 18151 | 21 CFR 117.40(f) | Instruments and Controls |
| 18161 | 21 CFR 117.80(c) | Manufacturing, processing, packing, holding - Controls |
| 19038 | 21 CFR 117.145(c)(1) | Process Controls Monitoring Records |
| 21275 | 21 CFR 117.206(a)(5) | Modified requirement: Temperature control - Records |