FDA Inspection
Genesis Pharmaceutical, Inc.Genesis Pharmaceutical, Inc. – FDA Inspection, Jul 16, 2010
Record Details
This FDA Inspection record concerns Genesis Pharmaceutical, Inc., with an inspection on July 16, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Genesis Pharmaceutical, Inc.
- Inspection Date
- July 16, 2010
- Product Type
- Drugs
View Company Profile
ID · d1ba8b91-15a5-4829-9656-9fcd86e1b502
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 672907
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.100(b)SOPs not followed / documented
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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 |
| 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 797953 - 2012-09-13
- FDA Inspection 611313 - 2009-09-11
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