FDA Inspection
Genus Lifesciences Inc.Genus Lifesciences Inc. – FDA Inspection, Sep 20, 2019
Record Details
This FDA Inspection record concerns Genus Lifesciences Inc., with an inspection on September 20, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · d4bb2b33-6870-4642-b369-ed0acb422c35
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1102370
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
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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 |
| 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 |
| August 11, 2016 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Genus Lifesciences Inc.
- FDA Inspection 1245779 - 2024-07-31
- FDA Inspection 1073444 - 2018-11-28
- FDA Inspection 1059468 - 2018-07-20
- FDA Inspection 1027671 - 2017-09-29
- FDA Inspection 982555 - 2016-08-11
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