FDA Inspection
Geritrex CorporationGeritrex Corporation – FDA Inspection, Dec 14, 2009
Record Details
This FDA Inspection record concerns Geritrex Corporation, with an inspection on December 14, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Geritrex Corporation
- Inspection Date
- December 14, 2009
- Product Type
- Drugs
View Company Profile
ID · 53d7361d-7951-4041-8ea2-6fd2a9e579ee
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 635067
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.115(b)Reprocessing/quality control unit
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.52Washing and toilet facilities not provided and accessible
- 21 CFR 211.100(b)SOPs not followed / documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Geritrex Corporation
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 18, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| February 2, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 19, 2015 | VAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
| March 21, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 7, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Geritrex Corporation
- FDA Inspection 1049910 - 2018-04-18
- FDA Inspection 1039787 - 2018-02-02
- FDA Inspection 951723 - 2015-10-19
- FDA Inspection 872376 - 2014-03-21
- FDA Inspection 710767 - 2011-02-07
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