FDA Inspection
Vortran Medical Technology 1, IncVortran Medical Technology 1, Inc – FDA Inspection, Apr 11, 2017
Record Details
This FDA Inspection record concerns Vortran Medical Technology 1, Inc, with an inspection on April 11, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b2692bbc-45ae-4184-ac2d-5105109a8cc3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1010791
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.72(a)Equipment suitability & capability
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of Vortran Medical Technology 1, Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 17, 2024 | Not classified | San Francisco District Office | |
| May 29, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 26, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Vortran Medical Technology 1, Inc
- FDA Inspection 1246791 - 2024-07-17
- FDA Inspection 834679 - 2013-05-29
- FDA Inspection 566225 - 2009-02-26
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