FDA Inspection 1162562 — Bonafide Innovations LLC
The FDA completed an inspection of Bonafide Innovations LLC on Feb 18, 2022 in Irving, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 18, 2022
- Fiscal Year
- 2022
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Irving, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15790 | 21 CFR 111.403 | Written procedures - labeling operations |
| 15791 | 21 CFR 111.403 | Written procedures -packaging operations |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15933 | 21 CFR 111.105(b) | Quality control - supplier qualification |
| 18143 | 21 CFR 117.35(b)(1) | Cleaning and sanitizing substances - Safe and adequate |
| 18151 | 21 CFR 117.40(f) | Instruments and Controls |
| 18398 | 21 CFR 117.4 | Training of employees and records |
| 3062 | 21 CFR 114.10 | Personnel |
| 3080 | 21 CFR 114.83 | Scheduled process establishment |