FDA Inspection
Robert Busse & Co., Inc.Robert Busse & Co., Inc. – FDA Inspection, Oct 19, 2016
Record Details
This FDA Inspection record concerns Robert Busse & Co., Inc., with an inspection on October 19, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · bfe247ab-e681-4a46-9688-c7f46d170e10
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 993771
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.68(b)Backup data not assured as exact and complete
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.186QSR
- 21 CFR 820.90(a)Nonconforming product control
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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 |
| 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 1048678 - 2018-04-13
- 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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