FDA Inspection 800284 — Fabrica Confecciones Soto, Inc.
The FDA completed an inspection of Fabrica Confecciones Soto, Inc. on September 18, 2012 in Canovanas, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 18, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Canovanas, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1429 | 21 CFR 110.20(b)(6) | Fans/air blowing equipment |
| 1556 | 21 CFR 110.35(b)(2) | Storage requirements |
| 1560 | 21 CFR 110.35(c) | Lack of effective pest exclusion |
| 1566 | 21 CFR 110.35(d)(4) | Single-service articles |
| 2386 | 21 CFR 110.80(a)(1) | Storage |
| 2392 | 21 CFR 110.80(b)(1) | Maintenance of equip., utensils, and finished food packaging |
| 3652 | 21 CFR 110.37(e)(1) | Suitable locations |
| 901 | 21 CFR 123.6(a) | Hazard analysis |
| 904 | 21 CFR 123.6(b) | No HACCP plan |