FDA Inspection 1117034 — RFI, LLC.
The FDA completed an inspection of RFI, LLC. on January 28, 2020 in Broomfield, CO. 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
- January 28, 2020
- Fiscal Year
- 2020
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Broomfield, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15645 | 21 CFR 111.455(c) | Hold - mix-up, contamination, deterioration |
| 15660 | 21 CFR 111.475(b)(2) | Records - product distribution |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |
| 15751 | 21 CFR 111.210(d) | Master manufacturing record - Supplemental Facts |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15862 | 21 CFR 111.75(a)(2) | Appropriate tests, examinations; certificate of analysis |
| 15871 | 21 CFR 111.75(c)(2) | Specifications met - test, examinations; compliance |
| 15967 | 21 CFR 111.117(b) | Quality control operations - calibration records |