Company
United StatesHiossen Inc., Fairless Hills, PA – FDA Inspections
Inspection records and compliance data for Hiossen Inc. in Fairless Hills, Pennsylvania. 3 FDA inspections on record (1 OAI), 1 Form 483, last inspected April 12, 2017.
Company Profile
This profile covers Hiossen Inc. based in Fairless Hills, Pennsylvania, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected May 16, 2012. Last inspected April 12, 2017.
Most cited issue areas
- Management review - defined interval, sufficient frequency1 inspection
- Production and Process Change Procedures, lack of or Inad.1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 12, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1007913 |
| April 18, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 831555 |
| May 16, 2012 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 781029 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Hiossen Inc.
FEI Number
3007135442
Address
85 Ben Fairless Dr, Fairless Hills, Pennsylvania 19030, United States
Country
United States
ID: d384b90a-dcb2-4020-acd1-2195a0ef67d9