FDA Inspection 1233592 — NatureKue Inc
The FDA completed an inspection of NatureKue Inc on Mar 20, 2024 in Rockville, MD. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Mar 20, 2024
- Fiscal Year
- 2024
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Rockville, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15862 | 21 CFR 111.75(a)(2) | Appropriate tests, examinations; certificate of analysis |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15950 | 21 CFR 111.110(b) | Quality control operations - tests, examinations |
| 15951 | 21 CFR 111.110(c) | Quality control operations - tests, examinations; results |
| 15963 | 21 CFR 111.113(b)(2) | Quality control - reject; specification not met |
| 15977 | 21 CFR 111.123(a)(1) | Quality control operations - master manufacturing record, modifications |
| 15984 | 21 CFR 111.123(a)(8) | Quality control - finished batch, distribution |