Company
United StatesEpimed International, Inc., Johnstown, NY – FDA Inspections
Inspection records and compliance data for Epimed International, Inc. in Johnstown, New York. 6 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected December 12, 2018.
Company Profile
This profile covers Epimed International, Inc. based in Johnstown, New York, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 1
- VAI
- 3
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 1
First inspected April 13, 2010. Last inspected December 12, 2018.
Most cited issue areas
- Documentation2 inspections
- Lack of or inadequate complaint procedures2 inspections
- Lack of or inadequate procedures2 inspections
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 12, 2018 | Not classified | Medical Devices & Rad Health | 1094942 |
| July 12, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 977666 |
| November 6, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 855890 |
| March 26, 2013 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 823868 |
| May 17, 2012 | OAI | Medical Devices & Rad Health · Compliance: Devices | 781198 |
| April 13, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 657836 |
FDA documents
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Epimed International, Inc.
FEI Number
1316297
Address
141 Sal Landrio Dr, Johnstown, New York 12095, United States
Country
United States
ID: 14e34d55-938e-4bdb-87b2-568de3de45c1