FDA Inspection
Andersen Products, Inc.Andersen Products, Inc. – FDA Inspection, Nov 29, 2011
Record Details
This FDA Inspection record concerns Andersen Products, Inc., with an inspection on November 29, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Andersen Products, Inc.
- Inspection Date
- November 29, 2011
- Product Type
- Devices
View Company Profile
ID · 60433681-191d-4a75-a12d-b1dda75370ad
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 774266
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.25(b)Training records
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - Risk analysis
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Andersen Products, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 14, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Andersen Products, Inc.
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.