FDA Inspection 1179517 — KDC/ONE SOCAL LABORATORIES, LLC
The FDA completed an inspection of KDC/ONE SOCAL LABORATORIES, LLC on September 13, 2022 in Walnut, 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
- September 13, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Walnut, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |