FDA Inspection
Danmar Products, Inc.Danmar Products, Inc. – FDA Inspection, Jan 15, 2009
Record Details
This FDA Inspection record concerns Danmar Products, Inc., with an inspection on January 15, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Danmar Products, Inc.
- Inspection Date
- January 15, 2009
- Product Type
- Devices
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ID · fc5df629-0dc7-4163-a632-5a7b96f16d2e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 554943
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
12- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 21 CFR 820.80(c)Documentation
- 21 CFR 820.198(a)(1)Uniform and timely processing
- 21 CFR 820.20(b)(3)Management representative
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.181(c)DMR QA procedures and specifications
- 21 CFR 820.100(b)Procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
Showing 10 of 12 citations.
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Other FDA inspections of Danmar Products, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 4, 2024 | NAI | Detroit District Office | Postmarket Assurance: Medical Devices |
| November 15, 2017 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 30, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 1, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 12, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Danmar Products, Inc.
- FDA Inspection 1252815 - 2024-11-04
- FDA Inspection 1032276 - 2017-11-15
- FDA Inspection 901058 - 2014-10-30
- FDA Inspection 803877 - 2012-10-01
- FDA Inspection 658929 - 2010-04-12
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