FDA Inspection
Battle Creek Equipment Co.Battle Creek Equipment Co. – FDA Inspection, Oct 11, 2018
Record Details
This FDA Inspection record concerns Battle Creek Equipment Co., with an inspection on October 11, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · cb60405f-061f-4139-9ce5-75cb7805e868
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1069066
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
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Other FDA inspections of Battle Creek Equipment Co.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| May 31, 2017 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 10, 2016 | 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 1012495 - 2017-05-31
- FDA Inspection 959469 - 2016-02-10
- FDA Inspection 914951 - 2015-02-12
- FDA Inspection 844937 - 2013-08-01
- FDA Inspection 799639 - 2012-09-13
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