Company
United StatesDynarex Corporation, Orangeburg, NY – FDA Inspections
Inspection records and compliance data for Dynarex Corporation in Orangeburg, New York. 5 FDA inspections on record, 2 Form 483s, last inspected November 16, 2018.
Company Profile
This profile covers Dynarex Corporation based in Orangeburg, New York, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected February 20, 2009. Last inspected November 16, 2018.
Most cited issue areas
- Acceptable supplier records1 inspection
- Acceptable supplier records, inadequate records1 inspection
- CAPA verification/validation of corrective/preventive action1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 16, 2018 | Not classified | Medical Devices & Rad Health | 1102050 |
| March 2, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1005494 |
| March 31, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 873247 |
| December 20, 2011 | NAI | Foods & Cosmetics, Medical Devices & Rad Health · Compliance: Devices | 762080 |
| February 20, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 567627 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Dynarex Corporation
FEI Number
2431014
Address
10 Glenshaw St, Orangeburg, New York 10962, United States
Country
United States
ID: d0ad5d28-76a3-455f-9f9a-7e55d93edced