FDA Inspection
Harmac Medical Products, Ltd.Harmac Medical Products, Ltd. – FDA Inspection, Mar 6, 2014
Record Details
This FDA Inspection record concerns Harmac Medical Products, Ltd., with an inspection on March 6, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- March 6, 2014
- Product Type
- Devices
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ID · 1ad4da52-3cd9-4f28-b7af-4b245d040a69
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 872440
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.100(a)Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Harmac Medical Products, Ltd.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 1, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 31, 2020 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 1, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 14, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Harmac Medical Products, Ltd.
- FDA Inspection 1208757 - 2023-06-01
- FDA Inspection 1123179 - 2020-01-31
- FDA Inspection 967590 - 2016-04-01
- FDA Inspection 828032 - 2013-03-14
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