FDA Inspection 1312606 — KDC/ONE SOCAL LABORATORIES, LLC
The FDA completed an inspection of KDC/ONE SOCAL LABORATORIES, LLC on Apr 14, 2026 in Walnut, CA. 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 14, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Walnut, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1917 | 21 CFR 211.166(a)(1) | Sample size - test intervals |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |