FDA Inspection
Geritrex CorporationGeritrex Corporation – FDA Inspection, Feb 7, 2011
Record Details
This FDA Inspection record concerns Geritrex Corporation, with an inspection on February 7, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Geritrex Corporation
- Inspection Date
- February 7, 2011
- Product Type
- Drugs
View Company Profile
ID · 16145f90-1051-4f76-96ee-3e3a5d06677d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 710767
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.122(b)Labeling and packaging improperly approved/released
- 21 CFR 211.194(a)(2)Statement of methods and data
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
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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 |
| December 14, 2009 | 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 635067 - 2009-12-14
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