FDA Inspection 1095162 — Nkulenu Industries Limited
The FDA completed an inspection of Nkulenu Industries Limited on June 24, 2019 in Madina. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 24, 2019
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Madina (Ghana)
Citations
| ID | CFR | Description |
|---|---|---|
| 1316 | 21 CFR 113.87(c) | Initial temperature of container contents |
| 1483 | 21 CFR 113.87(a) | Operating processes not posted |
| 1648 | 21 CFR 113.40(a)(1) | No TID |
| 1735 | 21 CFR 113.40(a)(2)(iii) | Unauthorized adjustment |
| 18148 | 21 CFR 117.37 | Sanitary facilities and controls |
| 18149 | 21 CFR 117.40 | Equipment and utensils - Design and maintenance |
| 3857 | 21 CFR 113.60(a) | Record: visual closure examination, qualified person |
| 3865 | 21 CFR 113.60(a)(1) | Teardown examinations - record of corrective action |
| 3877 | 21 CFR 113.60(c) | Coding - required elements |
| 4519 | 21 CFR 108.35(c)(3)(i) | Process adherence |
| 4524 | 21 CFR 108.35(g) | Approved school |