Company
United StatesWestern/Scott Fetzer Company, Westlake, OH – FDA Inspections
Inspection records and compliance data for Western/Scott Fetzer Company in Westlake, Ohio. 5 FDA inspections on record (1 OAI), 2 Form 483s, 1 warning letter, last inspected August 29, 2018.
Company Profile
This profile covers Western/Scott Fetzer Company based in Westlake, Ohio, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 2
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 1
First inspected May 27, 2010. Last inspected August 29, 2018.
Most cited issue areas
- Purchasing controls, Lack of or inadequate procedures3 inspections
- Documentation2 inspections
- Documentation - review in response to changes or deviations1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 29, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1064635 |
| August 8, 2018 | Not classified | Medical Devices & Rad Health | 1134007 |
| August 12, 2016 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 981670 |
| September 2, 2014 | OAI | Medical Devices & Rad Health · Compliance: Devices | 889918 |
| May 27, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 663119 |
FDA documents
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Western/Scott Fetzer Company
FEI Number
1526809
Address
875 Bassett Rd, Westlake, Ohio 44145, United States
Country
United States
ID: 2defa5eb-05a9-4194-b94c-e2c7bb52d913