FDA Inspection 855816 — Infiniti Labs, LLC
The FDA completed an inspection of Infiniti Labs, LLC on Nov 7, 2013 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). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 7, 2013
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Lindon, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15607 | 21 CFR 111.165(c)(2) | Product received - quality control; documentation; specs |
| 15617 | 21 CFR 111.180(a) | Records - comp, package, labels, product received: Available |
| 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 |
| 15901 | 21 CFR 111.83(b)(3) | Reserve sample - retained |
| 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 |