FDA Inspection
Battle Creek Equipment Co.Battle Creek Equipment Co. – FDA Inspection, Feb 10, 2016
Record Details
This FDA Inspection record concerns Battle Creek Equipment Co., with an inspection on February 10, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Battle Creek Equipment Co.
- Inspection Date
- February 10, 2016
- Product Type
- Devices
View Company Profile
ID · 7758bd60-66a7-4099-b3bd-7b7858a89733
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 959469
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 820.80(e)Documentation
- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.72(b)Calibration procedures - content
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Battle Creek Equipment Co.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| October 11, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 31, 2017 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 12, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 1, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 13, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Battle Creek Equipment Co.
- FDA Inspection 1069066 - 2018-10-11
- FDA Inspection 1012495 - 2017-05-31
- FDA Inspection 914951 - 2015-02-12
- FDA Inspection 844937 - 2013-08-01
- FDA Inspection 799639 - 2012-09-13
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.