FDA Inspection 1278916 — SV Labs Corporation
The FDA completed an inspection of SV Labs Corporation on Oct 23, 2025 in Watsonville, CA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Oct 23, 2025
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Watsonville, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 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 |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 4373 | 21 CFR 211.188(b)(7) | Actual yield, % of theoretical yield |