FDA Inspection
Poly-Med IncPoly-Med Inc – FDA Inspection, Sep 23, 2016
Record Details
This FDA Inspection record concerns Poly-Med Inc, with an inspection on September 23, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Poly-Med Inc
- Inspection Date
- September 23, 2016
- Product Type
- Devices
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ID · 5a38c2b3-9c78-40b3-9a86-c17c481b9107
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 989787
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.100(b)Documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Poly-Med Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 22, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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