FDA Inspection 1312864 — Neurogan, Inc.
The FDA completed an inspection of Neurogan, Inc. on April 17, 2026 in San Diego, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 17, 2026
- Fiscal Year
- 2026
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- San Diego, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15785 | 21 CFR 111.410(b) | Label, packaging - discrepancies |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 15984 | 21 CFR 111.123(a)(8) | Quality control - finished batch, distribution |
| 22836 | 21 CFR 111.27(a) | Equipment - design - appropriate and suitable |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22863 | 21 CFR 111.110 | Quality control - Laboratory control processes; production, process control |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |
| 22894 | 21 CFR 111.315(b) | Sampling plans; establish, follow |
| 22900 | 21 CFR 111.403 | Written procedures - establish; packaging & labeling |
| 22908 | 21 CFR 111.503 | Written procedures - establish; returned dietary supplements |
| 22912 | 21 CFR 111.560(a) | Product complaint - qualified person review & investigate |
| 22916 | 21 CFR 111.570(b)(2)(ii) | Record - product complaint; written record information |