FDA Inspection
POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLCPOLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC – FDA Inspection, Sep 7, 2012
Record Details
This FDA Inspection record concerns POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC, with an inspection on September 7, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 7, 2012
- Product Type
- Devices
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ID · 94a23df7-41c4-4571-8b39-cd92740c31c2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 803083
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 806.10(b)Time to report - 10 days
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.50(a)(1)Documented evaluation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 3, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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