FDA Inspection
Wells Johnson CompanyWells Johnson Company – FDA Inspection, Mar 22, 2017
Record Details
This FDA Inspection record concerns Wells Johnson Company, with an inspection on March 22, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 2f210c6a-33f0-4684-bd65-d56a90b8ed40
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1006128
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.30(b)Design plans- updated
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Wells Johnson Company
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 6, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 26, 2020 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 23, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 30, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Wells Johnson Company
- FDA Inspection 1229205 - 2024-02-06
- FDA Inspection 1119224 - 2020-02-26
- FDA Inspection 774679 - 2012-03-23
- FDA Inspection 561493 - 2009-01-30
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