FDA Inspection 1235654 — Genentech, Inc.
The FDA completed an inspection of Genentech, Inc. on Apr 19, 2024 in Hillsboro, 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 19, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hillsboro, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 21297 | 21 CFR 211.186(a) | Master production and control records, procedure |
| 2402 | 21 CFR 211.194(a)(5) | Testing Calculations |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |