FDA Inspection
BEST THERATRONICS LTD.BEST THERATRONICS LTD. – FDA Inspection, Jan 26, 2017
Record Details
This FDA Inspection record concerns BEST THERATRONICS LTD., with an inspection on January 26, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Wendy R. Blame (Issuing Officer)
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ID · be23ba2e-1e2e-4003-94be-c6a5c1732911
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1002836
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality Audits - defined intervals
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Other FDA inspections of BEST THERATRONICS LTD.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 6, 2018 | Not classified | Office of Inspections and Investigations |
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