FDA Inspection 1107476 — Lea-Way Farms Inc.
The FDA completed an inspection of Lea-Way Farms Inc. on Oct 25, 2019 in Statesville, NC. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 14 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Oct 25, 2019
- Fiscal Year
- 2020
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Statesville, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 13571 | 21 CFR 589.2001(c)(3)(i) | Records:establish, maintain, make available |
| 18197 | 21 CFR 507.14 | Personnel |
| 18198 | 21 CFR 507.17(a) | Grounds |
| 18201 | 21 CFR 507.19(a) | Plant Maintenance |
| 18202 | 21 CFR 507.19(b) | Sanitation |
| 18203 | 21 CFR 507.19(c) | Cleaning Compounds |
| 18204 | 21 CFR 507.19(d)(2) | Toxic Substances |
| 18208 | 21 CFR 507.20 | Water Supply and Plumbing |
| 18217 | 21 CFR 507.25(a) | Plant Operations |
| 18219 | 21 CFR 507.25(b)(1) | Raw Material Controls |
| 18221 | 21 CFR 507.25(b)(3) | Frozen Raw Materials/Ingredients |
| 18223 | 21 CFR 507.25(c)(2) | Manufacturing, Processing, Packing, Holding - Measures |
| 18231 | 21 CFR 507.27(b) | Labeling of Stored/Distributed Animal Food |
| 21343 | 21 CFR 507.202(b) | Requirements Included on Record |