FDA Inspection 954919 — Infiniti Labs, LLC
The FDA completed an inspection of Infiniti Labs, LLC on Nov 25, 2015 in Lindon, UT. 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). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 25, 2015
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Lindon, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15459 | 21 CFR 111.20(d) | Physical plant - design and construction |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15567 | 21 CFR 111.260(l)(4) | Batch record - approved, released, rejected |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15853 | 21 CFR 111.73 | Specifications met - identity, purity, strength, composition |
| 15933 | 21 CFR 111.105(b) | Quality control - supplier qualification |
| 15989 | 21 CFR 111.127 | Quality control operations - packaging, labeling |
| 16040 | 21 CFR 111.610(a) | Records - available; FDA |