FDA Inspection
Madison Polymeric EngineeringMadison Polymeric Engineering – FDA Inspection, Oct 26, 2011
Record Details
This FDA Inspection record concerns Madison Polymeric Engineering, with an inspection on October 26, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 26, 2011
- Product Type
- Devices
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ID · af41eff5-1e0f-4e57-ac21-51e2fe410b4d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 753106
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.25(b)Training records
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 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 |
| 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 |
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