FDA Inspection
Robert Busse & Co., Inc.Robert Busse & Co., Inc. – FDA Inspection, Apr 13, 2018
Record Details
This FDA Inspection record concerns Robert Busse & Co., Inc., with an inspection on April 13, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ed8ed895-324b-4d60-8803-a05263018c32
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1048678
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
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Other FDA inspections of Robert Busse & Co., Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 19, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 27, 2015 | VAI | Center for Devices and Radiological Health | Compliance: 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 993771 - 2016-10-19
- FDA Inspection 918565 - 2015-02-27
- FDA Inspection 802601 - 2012-10-10
- FDA Inspection 719303 - 2011-04-11
- FDA Inspection 546561 - 2008-11-07
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