FDA Inspection 889833 — Element Materials Technology Oakland-Concord
The FDA completed an inspection of Element Materials Technology Oakland-Concord on Jul 8, 2014 in Concord, 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 8, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Concord, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3614 | 21 CFR 211.160(b)(4) | Written calibration procedures |