FDA Inspection 1101324 — Bulletproof 360 Inc
The FDA completed an inspection of Bulletproof 360 Inc on September 6, 2019 in Oakland, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 6, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Oakland, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15819 | 21 CFR 111.55 | Production, process controls - implement |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 21276 | 21 CFR 117.405(a)(1) | Supply-Chain Program Establish and Implement |