FDA Inspection
Robert Busse & Co., Inc.Robert Busse & Co., Inc. – FDA Inspection, Oct 10, 2012
Record Details
This FDA Inspection record concerns Robert Busse & Co., Inc., with an inspection on October 10, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Robert Busse & Co., Inc.
- Inspection Date
- October 10, 2012
- Product Type
- Devices
View Company Profile
ID · 9fe737f2-3738-40ad-8940-7b3279fca3c1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 802601
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 803.56Submission of Supplement to Individual Report Within One Month
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
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 |
| February 27, 2015 | VAI | Center for Devices and Radiological Health | Compliance: 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 918565 - 2015-02-27
- FDA Inspection 719303 - 2011-04-11
- FDA Inspection 546561 - 2008-11-07
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.