FDA Inspection
Battle Creek Equipment Co.Battle Creek Equipment Co. – FDA Inspection, May 31, 2017
Record Details
This FDA Inspection record concerns Battle Creek Equipment Co., with an inspection on May 31, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c5fee948-b1e9-4f0c-b006-096b1e3f90b5
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1012495
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 820.80(e)Documentation
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
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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 |
| 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 1069066 - 2018-10-11
- 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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