FDA Inspection
Madison Polymeric EngineeringMadison Polymeric Engineering – FDA Inspection, Mar 23, 2015
Record Details
This FDA Inspection record concerns Madison Polymeric Engineering, with an inspection on March 23, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- March 23, 2015
- Product Type
- Devices
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ID · 69889cb4-ecaf-4a80-be98-e9bdd0093a0e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 919396
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(a)(5)Changes to correct/prevent quality problems
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
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Other FDA inspections of Madison Polymeric Engineering
5| Date | Classification | Office | Project area |
|---|---|---|---|
| February 22, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 3, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 12, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 9, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 26, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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