FDA Inspection 935773 — Fabrica Confecciones Soto, Inc.
The FDA completed an inspection of Fabrica Confecciones Soto, Inc. on July 24, 2015 in Canovanas, PR. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 24, 2015
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Canovanas, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1525 | 21 CFR 123.11(c) | Sanitation Records |
| 1560 | 21 CFR 110.35(c) | Lack of effective pest exclusion |
| 2392 | 21 CFR 110.80(b)(1) | Maintenance of equip., utensils, and finished food packaging |
| 6005 | 21 CFR 123.6(c)(6) | Verification procedures - adequacy |
| 6008 | 21 CFR 123.8(a)(3) | Verification - record review - frequency |
| 6010 | 21 CFR 123.8(a)(3)(i) | Monitoring record review adequacy |
| 6012 | 21 CFR 123.8(a)(3)(iii) | Calibration record review adequacy |
| 6019 | 21 CFR 123.8(a)(2) | Ongoing verification - complaints, calibration records |
| 6020 | 21 CFR 123.9(a) | Records - content |
| 6021 | 21 CFR 123.10 | HACCP training or qualification |
| 906 | 21 CFR 123.6(b) | HACCP plan location |
| 960 | 21 CFR 123.6(c)(2) | Critical control points |