FDA Inspection
Genesis Pharmaceutical, Inc.Genesis Pharmaceutical, Inc. – FDA Inspection, Sep 13, 2012
Record Details
This FDA Inspection record concerns Genesis Pharmaceutical, Inc., with an inspection on September 13, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Genesis Pharmaceutical, Inc.
- Inspection Date
- September 13, 2012
- Product Type
- Drugs
View Company Profile
ID · 0314996c-16fc-4938-9500-559742d26ab4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 797953
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.130(a)Prevention of cross contamination, mix-ups
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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 |
| July 16, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 11, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Genesis Pharmaceutical, Inc.
- FDA Inspection 888937 - 2014-06-12
- FDA Inspection 672907 - 2010-07-16
- FDA Inspection 611313 - 2009-09-11
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