FDA Inspection 1017630 — Brain Alert LLC
The FDA completed an inspection of Brain Alert LLC on July 12, 2017 in Lynnwood, WA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 12, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Lynnwood, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15642 | 21 CFR 111.455(a) | Hold - temperature, humidity, light |
| 15728 | 21 CFR 111.365(d) | Chemical, microbiological, other test-contaminated components |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15819 | 21 CFR 111.55 | Production, process controls - implement |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15928 | 21 CFR 111.103 | Written procedure quality control operations material review |