FDA Inspection
Genentech, Inc.FDA Inspection 1235654 - Genentech, Inc. - April 19, 2024
Record Details
This FDA Inspection record concerns Genentech, Inc., with an inspection on April 19, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · cfc2813c-853b-4f2b-aadf-259e3cef88a4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1235654
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(5)Testing Calculations
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.186(a)Master production and control records, procedure
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.192Written record of investigation incomplete
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Genentech, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| July 5, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 15, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 1, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 27, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 17, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Genentech, Inc.
- FDA Inspection 1057924 - 2018-07-05
- FDA Inspection 975839 - 2016-04-15
- FDA Inspection 888022 - 2014-07-01
- FDA Inspection 791162 - 2012-06-27
- FDA Inspection 639721 - 2009-12-17
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