FDA Inspection
MAST Biosurgery USA IncMAST Biosurgery USA Inc – FDA Inspection, Sep 13, 2018
Record Details
This FDA Inspection record concerns MAST Biosurgery USA Inc, with an inspection on September 13, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 7e93ab92-5ab7-4433-80f1-9c04326c7f20
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1065604
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of MAST Biosurgery USA Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 21, 2025 | Not classified | Los Angeles District Office | Compliance: Medical Devices |
| November 19, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 3, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 8, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 20, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for MAST Biosurgery USA Inc
- FDA Inspection 1279116 - 2025-08-21
- FDA Inspection 1157029 - 2021-11-19
- FDA Inspection 908953 - 2014-12-03
- FDA Inspection 843883 - 2013-08-08
- FDA Inspection 677463 - 2010-08-20
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