FDA Inspection
Geritrex CorporationGeritrex Corporation – FDA Inspection, Oct 19, 2015
Record Details
This FDA Inspection record concerns Geritrex Corporation, with an inspection on October 19, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Geritrex Corporation
- Inspection Date
- October 19, 2015
- Product Type
- Drugs
View Company Profile
ID · baca6ab8-5950-424e-b142-5b1093218977
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 951723
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
4- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.110(a)Written in-process control procedures
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 |
| 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 |
| 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 872376 - 2014-03-21
- FDA Inspection 710767 - 2011-02-07
- FDA Inspection 635067 - 2009-12-14
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.