FDA Inspection
East West WisconsinEast West Wisconsin – FDA Inspection, Jun 15, 2017
Record Details
This FDA Inspection record concerns East West Wisconsin, with an inspection on June 15, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · eb3a74a1-8afe-4e82-886d-23869b21a55c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1017482
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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Other FDA inspections of East West Wisconsin
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 26, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 6, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for East West Wisconsin
- FDA Inspection 1251923 - 2024-09-26
- FDA Inspection 945304 - 2015-08-06
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