FDA Inspection 1017072 — Realm Labs, LLC
The FDA completed an inspection of Realm Labs, LLC on July 7, 2017 in Boca Raton, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 7, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Boca Raton, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15843 | 21 CFR 111.70(g) | Specifications - finished packaging, labeling |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |