FDA Inspection
WellSky CorporationWellSky Corporation – FDA Inspection, Sep 26, 2019
Record Details
This FDA Inspection record concerns WellSky Corporation, with an inspection on September 26, 2019, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · a7a66970-acbd-4c94-b154-b6678dc0e371
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1102860
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of WellSky Corporation
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 16, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| September 19, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 8, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 17, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for WellSky Corporation
- FDA Inspection 1173378 - 2022-06-16
- FDA Inspection 1106453 - 2019-09-19
- FDA Inspection 886876 - 2014-07-08
- FDA Inspection 714733 - 2011-03-17
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.