Company
United StatesRepro-Med Systems, Inc., Chester, NY – FDA Inspections
Inspection records and compliance data for Repro-Med Systems, Inc. in Chester, New York. 6 FDA inspections on record (1 OAI), 2 Form 483s, last inspected October 19, 2017.
Company Profile
This profile covers Repro-Med Systems, Inc. based in Chester, New York, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 1
- VAI
- 1
- NAI
- 4
- Form 483s
- 2
- Warning letters
- 0
First inspected October 28, 2009. Last inspected October 19, 2017.
Most cited issue areas
- Lack of or inadequate procedures3 inspections
- Design changes - Lack of or Inadequate Procedures2 inspections
- Design verification - output does not meet input requirement2 inspections
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 19, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1029627 |
| December 16, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 996093 |
| June 23, 2015 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 929452 |
| July 20, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 793650 |
| September 21, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 683171 |
| October 28, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 627589 |
FDA documents
People (2)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Repro-Med Systems, Inc.
FEI Number
1318360
Address
24 Carpenter Rd, Chester, New York 10918, United States
Country
United States
ID: 33ca025a-ec91-4b0c-ae99-ac661170de7e