FDA Inspection
Genus Lifesciences Inc.Genus Lifesciences Inc. – FDA Inspection, Jul 7, 2009
Record Details
This FDA Inspection record concerns Genus Lifesciences Inc., with an inspection on July 7, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Genus Lifesciences Inc.
- Inspection Date
- July 7, 2009
- Product Type
- Drugs
View Company Profile
ID · 7dda3892-03d9-47dc-ad19-df4ac6bd71de
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 595677
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.188(b)(5)In-process and laboratory control results
- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.111Deviations of production time limits
- 21 CFR 211.111Establishment of time limitations
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Other FDA inspections of Genus Lifesciences Inc.
10| Date | Classification | Office | Project area |
|---|---|---|---|
| July 31, 2024 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 20, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 28, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| July 20, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 29, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Genus Lifesciences Inc.
- FDA Inspection 1245779 - 2024-07-31
- FDA Inspection 1102370 - 2019-09-20
- FDA Inspection 1073444 - 2018-11-28
- FDA Inspection 1059468 - 2018-07-20
- FDA Inspection 1027671 - 2017-09-29
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