FDA Inspection
Medical Techniques, Inc.Medical Techniques, Inc. – FDA Inspection, Jun 21, 2017
Record Details
This FDA Inspection record concerns Medical Techniques, Inc., with an inspection on June 21, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 80463d6f-666e-4123-bd30-19e9c546923e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1015188
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
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Other FDA inspections of Medical Techniques, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 29, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Medical Techniques, Inc.
- FDA Inspection 703538 - 2010-12-29
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