FDA Inspection 1082803 — Elwood International, Inc.
The FDA completed an inspection of Elwood International, Inc. on Mar 15, 2019 in Copiague, NY. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Mar 15, 2019
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Copiague, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18140 | 21 CFR 117.20(b) | Plant construction and design |
| 18151 | 21 CFR 117.40(f) | Instruments and Controls |
| 18153 | 21 CFR 117.80(a) | Plant operations - Precautions |
| 18398 | 21 CFR 117.4 | Training of employees and records |
| 18400 | 21 CFR 117.315 | Record retention |
| 19027 | 21 CFR 117.126(a)(1) | Food safety plan |
| 19036 | 21 CFR 117.145(a) | Process Controls Monitoring Procedures: Establish Implement |