FDA Inspection 1079045 — Premium Production, LLC
The FDA completed an inspection of Premium Production, LLC on February 8, 2019 in Hildale, UT. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 8, 2019
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Hildale, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15578 | 21 CFR 111.155(c) | Components - quarantine |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15790 | 21 CFR 111.403 | Written procedures - labeling operations |
| 15791 | 21 CFR 111.403 | Written procedures -packaging operations |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |