FDA Inspection 1300524 — Element Materials Technology Oakland-Concord
The FDA completed an inspection of Element Materials Technology Oakland-Concord on Jan 30, 2026 in Concord, CA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jan 30, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Concord, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1436 | 21 CFR 211.42(c)(10)(vi) | Equipment to control conditions |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |
| 4410 | 21 CFR 211.194(a)(5) | Calculations performed are in the records |