FDA Inspection 1060583 — Analytical Resource Laboratories LLC
The FDA completed an inspection of Analytical Resource Laboratories LLC on Jul 20, 2018 in Lehi, 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 20, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lehi, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4406 | 21 CFR 211.194(a)(2) | Suitability of testing methods verified |