FDA Inspection
Bioteque Taiwan Ltd.Bioteque Taiwan Ltd. – FDA Inspection, Dec 8, 2016
Record Details
This FDA Inspection record concerns Bioteque Taiwan Ltd., with an inspection on December 8, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 569495ec-1c09-4e10-83cc-0a38c6acb163
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 995273
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Bioteque Taiwan Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 23, 2020 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 8, 2016 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
| April 3, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Bioteque Taiwan Ltd.
- FDA Inspection 1118749 - 2020-01-23
- FDA Inspection 995272 - 2016-12-08
- FDA Inspection 877305 - 2014-04-03
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