FDA Inspection 1011382 — Nutritional Engineering Inc
The FDA completed an inspection of Nutritional Engineering Inc on May 3, 2017 in San Clemente, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 3, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- San Clemente, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15534 | 21 CFR 111.255(c) | Batch record - each step |
| 15547 | 21 CFR 111.260(g) | Batch record - results; monitoring |
| 15665 | 21 CFR 111.303 | Written procedures - tests, examinations; specifications met |
| 15745 | 21 CFR 111.210(h)(1) | Instructions; specifications; packaged, labeled |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 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 |
| 15871 | 21 CFR 111.75(c)(2) | Specifications met - test, examinations; compliance |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 15963 | 21 CFR 111.113(b)(2) | Quality control - reject; specification not met |