FDA Inspection
Kem Medical Products CorpKem Medical Products Corp – FDA Inspection, Jan 15, 2020
Record Details
This FDA Inspection record concerns Kem Medical Products Corp, with an inspection on January 15, 2020, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Kem Medical Products Corp
- Inspection Date
- January 15, 2020
- Product Type
- Devices
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ID · a27e28e9-6290-4f2c-b798-6b3e218a03ed
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1115221
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.198(a)Complaints
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Kem Medical Products Corp
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 21, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 21, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 10, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 27, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Kem Medical Products Corp
- FDA Inspection 1175436 - 2022-07-21
- FDA Inspection 1003651 - 2017-02-21
- FDA Inspection 791042 - 2012-07-10
- FDA Inspection 623870 - 2009-10-27
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