FDA Inspection 1263333 — Elwood International, Inc.
The FDA completed an inspection of Elwood International, Inc. on March 10, 2025 in Copiague, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 14 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 10, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Copiague, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18138 | 21 CFR 117.10 | Personnel |
| 18140 | 21 CFR 117.20(b) | Plant construction and design |
| 18145 | 21 CFR 117.35(c) | Pest control |
| 22706 | 21 CFR 117.135(a)(1) | Allergen preventive controls - Implement |
| 22709 | 21 CFR 117.135(a)(1) | Sanitation preventive controls - Implement |
| 22717 | 21 CFR 117.130(a)(1) | Hazard analysis - Identification of hazard |
| 22718 | 21 CFR 117.135(c)(1) | Process preventive controls - Appropriate (Adequate) |
| 22720 | 21 CFR 117.135(c)(3) | Sanitation preventive controls - Appropriate (Adequate) |
| 3071 | 21 CFR 114.80(a)(1) | Scheduled process |
| 3077 | 21 CFR 114.80(b) | Visible code |
| 3085 | 21 CFR 114.100(a) | Raw materials, packaging, finished product |
| 3086 | 21 CFR 114.100(b) | Maintenance of processing and production records |
| 3088 | 21 CFR 114.100(b) | Processing and production - required information |
| 4470 | 21 CFR 108.25(c)(2) | Process filing |