FDA Inspection
Kem Medical Products CorpKem Medical Products Corp – FDA Inspection, Oct 27, 2009
Record Details
This FDA Inspection record concerns Kem Medical Products Corp, with an inspection on October 27, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Kem Medical Products Corp
- Inspection Date
- October 27, 2009
- Product Type
- Devices
View Company Profile
ID · 19622308-fea7-4b95-bf14-6ef3e8e52cc1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 623870
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 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 |
| January 15, 2020 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 |
Other documents for Kem Medical Products Corp
- FDA Inspection 1175436 - 2022-07-21
- FDA Inspection 1115221 - 2020-01-15
- FDA Inspection 1003651 - 2017-02-21
- FDA Inspection 791042 - 2012-07-10
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