FDA Inspection
Biomedix WaiBiomedix Wai – FDA Inspection, Feb 17, 2010
Record Details
This FDA Inspection record concerns Biomedix Wai, with an inspection on February 17, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Biomedix Wai
- Inspection Date
- February 17, 2010
- Product Type
- Devices
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ID · f94eedb6-e4d7-4264-8665-fdb9b44debb9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 653468
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Biomedix Wai
6| Date | Classification | Office | Project area |
|---|---|---|---|
| November 18, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 3, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 31, 2019 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 8, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 9, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Biomedix Wai
- FDA Inspection 1255255 - 2024-11-18
- FDA Inspection 1171910 - 2022-06-03
- FDA Inspection 1110467 - 2019-10-31
- FDA Inspection 1056265 - 2018-06-08
- FDA Inspection 952092 - 2015-12-09
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