FDA Inspection
Madison Polymeric EngineeringMadison Polymeric Engineering – FDA Inspection, Apr 12, 2016
Record Details
This FDA Inspection record concerns Madison Polymeric Engineering, with an inspection on April 12, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 12, 2016
- Product Type
- Devices
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ID · d15f0b67-9f42-43b1-88f9-760e24e1c159
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 966463
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.70(g)Equipment design and installation
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
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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 |
| March 23, 2015 | OAI | 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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