FDA Inspection
MAC Medical Inc.MAC Medical Inc. – FDA Inspection, Sep 16, 2026
Record Details
This FDA Inspection record concerns MAC Medical Inc., with an inspection on September 16, 2026, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- MAC Medical Inc.
- Inspection Date
- September 16, 2026
- Product Type
- Devices
View Company Profile
ID · 21586105-0fe2-4a5c-9d82-5a4af2d83c32
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1335940
- Project area
- Compliance: Devices
FDA Citations
3- ISO 13485:2016 Clause 4.1.6Monitoring and measurement requirements of product characteristics are not met
- ISO 13485:2016 Clause 4.1.3External party controls do not include written quality agreements
- ISO 13485:2016 Clause 4.1.6Monitoring and measurement requirements not determined
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Other FDA inspections of MAC Medical Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 26, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 29, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 8, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for MAC Medical Inc.
- FDA Inspection 1023514 - 2017-07-26
- FDA Inspection 783668 - 2012-05-29
- FDA Inspection 684786 - 2010-10-08
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