Company
United StatesHooper Holmes, Inc., Olathe, KS – FDA Inspections
Inspection records and compliance data for Hooper Holmes, Inc. in Olathe, Kansas. 5 FDA inspections on record (1 OAI), 1 Form 483, last inspected July 26, 2017.
Company Profile
This profile covers Hooper Holmes, Inc. based in Olathe, Kansas, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 3
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected June 23, 2010. Last inspected July 26, 2017.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Lack of or inadequate complaint procedures1 inspection
- Remedial action - documentation1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 26, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1019167 |
| March 7, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 821760 |
| June 17, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 730902 |
| April 18, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 719276 |
| June 23, 2010 | OAI | Medical Devices & Rad Health · Compliance: Devices | 670528 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Hooper Holmes, Inc.
FEI Number
1000118383
Address
560 N Rogers Rd, Olathe, Kansas 66062, United States
Country
United States
ID: 584062ed-9b31-4607-901a-3cff990ca45e