FDA Inspection
VicTorch Meditek, IncVicTorch Meditek, Inc – FDA Inspection, Sep 17, 2018
Record Details
This FDA Inspection record concerns VicTorch Meditek, Inc, with an inspection on September 17, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 930e89d0-9172-42cb-8d9c-73ba73908626
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1066293
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of VicTorch Meditek, Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 18, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 15, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 19, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for VicTorch Meditek, Inc
- FDA Inspection 1106828 - 2019-10-18
- FDA Inspection 895393 - 2014-09-15
- FDA Inspection 775766 - 2012-03-19
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