FDA Inspection
Genentech, Inc.FDA Inspection 1057924 - Genentech, Inc. - July 05, 2018
Record Details
This FDA Inspection record concerns Genentech, Inc., with an inspection on July 5, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Genentech, Inc.
- Inspection Date
- July 5, 2018
- Product Type
- Drugs
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ID · 0652dcc9-3388-4784-8145-c5d214c078b0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1057924
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.67(b)(2)Cleaning SOPs/schedules
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Genentech, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| April 19, 2024 | 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 1235654 - 2024-04-19
- 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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