FDA Inspection 1307704 — Kdc/One Chatsworth, Inc.
The FDA completed an inspection of Kdc/One Chatsworth, Inc. on Apr 3, 2026 in Chatsworth, CA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Apr 3, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chatsworth, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |