FDA Inspection
Genentech, Inc.Genentech, Inc. – FDA Inspection, Jun 23, 2011
Record Details
This FDA Inspection record concerns Genentech, Inc., with an inspection on June 23, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Genentech, Inc.
- Inspection Date
- June 23, 2011
- Product Type
- Drugs
View Company Profile
ID · 5444fdc5-eeb3-4b16-8149-0245813e6286
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 730740
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.42(c)(10)Aseptic Processing Area
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.192No written record of investigation
- 21 CFR 211.192Written record of investigation incomplete
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Genentech, Inc.
34| Date | Classification | Office | Project area |
|---|---|---|---|
| August 4, 2026 | Not classified | San Francisco District Office | |
| May 15, 2026 | Not classified | San Francisco District Office | |
| April 7, 2026 | Not classified | San Francisco District Office | |
| April 21, 2025 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| May 2, 2024 | VAI | Center for Drug Evaluation and Research | Postmarket Surv. and Epidemiology |
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- FDA Inspection 1314654 - 2026-04-07
- FDA Inspection 1263573 - 2025-04-21
- FDA Inspection 1236964 - 2024-05-02
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