FDA Inspection 1036644 — JWN Manufacturing
The FDA completed an inspection of JWN Manufacturing on January 3, 2018 in Plano, TX. 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
- January 3, 2018
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Plano, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15425 | 21 CFR 111.15(i) | Hand-washing facilities |
| 15434 | 21 CFR 111.15(d)(2) | Pest control measures |
| 15442 | 21 CFR 111.15(b)(1) | Physical plant - clean and sanitary |
| 15456 | 21 CFR 111.20(b) | Physical plant - space; equipment, materials |
| 15458 | 21 CFR 111.20(d)(1)(i) | Floors, walls, ceilings |
| 15475 | 21 CFR 111.20(e)(1) | Adequate light - processing, holding |
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15506 | 21 CFR 111.27(a)(4) | Equipment - bonded seams |
| 15544 | 21 CFR 111.260(d) | Batch record - component; unique identifier |
| 15784 | 21 CFR 111.410(c) | Packaging, labels - master manufacturing record |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 3080 | 21 CFR 114.83 | Scheduled process establishment |