FDA Inspection 1313690 — Optimal Solution Labs LLC
The FDA completed an inspection of Optimal Solution Labs LLC on April 17, 2026 in Valencia, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 17, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Valencia, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 3588 | 21 CFR 211.110(a)(3) | Mixing adequacy |