FDA Inspection
Robert Busse & Co., Inc.Robert Busse & Co., Inc. – FDA Inspection, Feb 27, 2015
Record Details
This FDA Inspection record concerns Robert Busse & Co., Inc., with an inspection on February 27, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Robert Busse & Co., Inc.
- Inspection Date
- February 27, 2015
- Product Type
- Devices
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ID · ca653ff5-fe52-4645-9b97-ceeee8eb985b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 918565
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.100(b)Documentation
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
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Other FDA inspections of Robert Busse & Co., Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 13, 2018 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 19, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 10, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 11, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 7, 2008 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Robert Busse & Co., Inc.
- FDA Inspection 1048678 - 2018-04-13
- FDA Inspection 993771 - 2016-10-19
- FDA Inspection 802601 - 2012-10-10
- FDA Inspection 719303 - 2011-04-11
- FDA Inspection 546561 - 2008-11-07
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