FDA Inspection
PolarSeal Tapes And Conversions, Ltd.FDA Inspection 1236894 - PolarSeal Tapes And Conversions, Ltd. - April 25, 2024
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Record Details
This FDA Inspection record concerns PolarSeal Tapes And Conversions, Ltd., with an inspection on April 25, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 0057e077-214f-42f7-8113-8571626bf423
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1236894
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.90(b)(2)Product rework adverse effects {see also 820.184}
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Other FDA inspections of PolarSeal Tapes And Conversions, Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 2, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |