FDA Inspection 1072026 — Element Materials Technology Bend, LLC
The FDA completed an inspection of Element Materials Technology Bend, LLC on November 16, 2018 in Bend, OR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 16, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bend, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |