Company
United StatesGeritrex Corporation, Middletown, NY – FDA Inspections
Inspection records and compliance data for Geritrex Corporation in Middletown, New York. 6 FDA inspections on record, 1 Form 483, last inspected April 18, 2018.
Company Profile
This profile covers Geritrex Corporation based in Middletown, New York, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 5
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected December 14, 2009. Last inspected April 18, 2018.
Most cited issue areas
- Absence of Written Procedures2 inspections
- Adequate number of batches on stability1 inspection
- Calibration - at intervals, written program, remedial action1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 18, 2018 | NAI | Human Drugs · Bioresearch Monitoring | 1049910 |
| February 2, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1039787 |
| October 19, 2015 | VAI | Human Drugs · Unapproved and Misbranded Drugs | 951723 |
| March 21, 2014 | VAI | Human Drugs · Drug Quality Assurance | 872376 |
| February 7, 2011 | VAI | Human Drugs · Drug Quality Assurance | 710767 |
| December 14, 2009 | VAI | Human Drugs · Drug Quality Assurance | 635067 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Geritrex Corporation
FEI Number
2433753
Address
40 Commercial Ave, Middletown, New York 10941, United States
Country
United States
ID: 49bf9de7-2c8d-4bbc-877b-e4d99a2e9590