FDA Inspection
Battle Creek Equipment Co.Battle Creek Equipment Co. – FDA Inspection, Feb 12, 2015
Record Details
This FDA Inspection record concerns Battle Creek Equipment Co., with an inspection on February 12, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Battle Creek Equipment Co.
- Inspection Date
- February 12, 2015
- Product Type
- Devices
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ID · f1106220-b609-44a5-83fb-a26acee78630
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 914951
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 803.17Lack of Written MDR Procedures
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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 |
| 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 |
| 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 959469 - 2016-02-10
- FDA Inspection 844937 - 2013-08-01
- FDA Inspection 799639 - 2012-09-13
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