FDA Inspection
Polar Products Inc.Polar Products Inc. – FDA Inspection, Mar 23, 2017
Record Details
This FDA Inspection record concerns Polar Products Inc., with an inspection on March 23, 2017, issued by the Cincinnati District Office, covering medical devices & rad health.
- Person
- Edward R. Kay (Issuing Officer)
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ID · 9bdd19a3-5550-47a9-9ff5-93356879ea1b
Inspection Facts
- Inspection number
- 1005496
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(a)(2)Supplier oversight
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Other FDA inspections of Polar Products Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 22, 2024 | Not classified | Cincinnati District Office | Compliance: Devices |
| August 4, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 17, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Polar Products Inc.
- FDA Inspection 1239262 - 2024-05-22
- FDA Inspection 1176422 - 2022-08-04
- FDA Inspection 862248 - 2014-01-17
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