FDA Inspection 1012077 — Brand New Energy, LLC
The FDA completed an inspection of Brand New Energy, LLC on May 24, 2017 in Burbank, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 24, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Burbank, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15437 | 21 CFR 111.15(a)(1) | Grounds - equipment, litter, weeds |
| 15442 | 21 CFR 111.15(b)(1) | Physical plant - clean and sanitary |
| 15458 | 21 CFR 111.20(d)(1)(i) | Floors, walls, ceilings |
| 15469 | 21 CFR 111.20(c)(3) | Physical plant - separate areas for products |
| 15481 | 21 CFR 111.23(b) | Records - cleaning, pest control |
| 15645 | 21 CFR 111.455(c) | Hold - mix-up, contamination, deterioration |
| 15646 | 21 CFR 111.460(a) | Hold, identify - in-process material |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |