FDA Inspection 1016970 — Lonza Bend Inc.
The FDA completed an inspection of Lonza Bend Inc. on June 30, 2017 in Bend, OR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 30, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bend, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1420 | 21 CFR 211.42(c)(9) | Control / Lab Operations Area |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |