Company
United StatesBattle Creek Equipment Co., Fremont, IN – FDA Inspections
Inspection records and compliance data for Battle Creek Equipment Co. in Fremont, Indiana. 8 FDA inspections on record (3 OAI), 2 Form 483s, 1 warning letter, last inspected October 11, 2018.
Company Profile
This profile covers Battle Creek Equipment Co. based in Fremont, Indiana, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 3
- VAI
- 4
- NAI
- 1
- Form 483s
- 2
- Warning letters
- 1
First inspected January 16, 2009. Last inspected October 11, 2018.
Most cited issue areas
- Documentation3 inspections
- Lack of or inadequate procedures3 inspections
- Management review - defined interval, sufficient frequency2 inspections
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 11, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1069066 |
| May 31, 2017 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1012495 |
| February 10, 2016 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 959469 |
| February 12, 2015 | OAI | Medical Devices & Rad Health · Compliance: Devices | 914951 |
| August 1, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 844937 |
| September 13, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 799639 |
| March 1, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 713130 |
| January 16, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 554275 |
FDA documents
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Battle Creek Equipment Co.
FEI Number
1833125
Address
702 S Reed Rd, Fremont, Indiana 46737, United States
Country
United States
ID: 35096a8a-e98f-4059-a160-8b230d3598c3