FDA Inspection 1234923 — FirstWave Innovations, Inc.
The FDA completed an inspection of FirstWave Innovations, Inc. on Apr 18, 2024 in Middlesex, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 18, 2024
- Fiscal Year
- 2024
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Middlesex, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18140 | 21 CFR 117.20(b) | Plant construction and design |
| 18141 | 21 CFR 117.35(a) | Sanitary operations - Plant maintenance |
| 18149 | 21 CFR 117.40 | Equipment and utensils - Design and maintenance |
| 18154 | 21 CFR 117.80(a)(2) | Appropriate quality control operations |
| 18158 | 21 CFR 117.80(b)(5) | Identification of rework |
| 18164 | 21 CFR 117.80(c)(9) | Adulterated food disposition |
| 22699 | 21 CFR 117.80(b)(1) | Raw material control - Inspection |
| 22703 | 21 CFR 117.135(a)(1) | Process preventive controls - Implement |
| 22706 | 21 CFR 117.135(a)(1) | Allergen preventive controls - Implement |
| 3078 | 21 CFR 114.80(b) | Code - required elements |