FDA Inspection 1072026 — Element Materials Technology Bend, LLC
The FDA completed an inspection of Element Materials Technology Bend, LLC on Nov 16, 2018 in Bend, OR. 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 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 |