FDA Inspection
Genesis Pharmaceutical, Inc.Genesis Pharmaceutical, Inc. – FDA Inspection, Sep 11, 2009
Record Details
This FDA Inspection record concerns Genesis Pharmaceutical, Inc., with an inspection on September 11, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Genesis Pharmaceutical, Inc.
- Inspection Date
- September 11, 2009
- Product Type
- Drugs
View Company Profile
ID · 3a159f35-d208-4395-a1c3-dccb1cfbaf57
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 611313
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.188(b)(12)Investigations made into any unexplained discrepancy
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.80(b)Handling and Storage to Prevent Contamination
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Other FDA inspections of Genesis Pharmaceutical, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 12, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 13, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 16, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Genesis Pharmaceutical, Inc.
- FDA Inspection 888937 - 2014-06-12
- FDA Inspection 797953 - 2012-09-13
- FDA Inspection 672907 - 2010-07-16
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