Company
United StatesWellSky Corporation, Overland Park, KS – FDA Inspections
Inspection records and compliance data for WellSky Corporation in Overland Park, Kansas. 5 FDA inspections on record, 1 Form 483, last inspected June 16, 2022.
Company Profile
This profile covers WellSky Corporation based in Overland Park, Kansas, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 1
- NAI
- 4
- Form 483s
- 1
- Warning letters
- 0
First inspected March 17, 2011. Last inspected June 16, 2022.
Most cited issue areas
- Lack of or inadequate procedures1 inspection
- Nonconforming product, Lack of or inadequate procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 16, 2022 | NAI | Biologics · Vaccines and Allergenic Products | 1173378 |
| September 26, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1102860 |
| September 19, 2019 | NAI | Biologics · Blood and Blood Products | 1106453 |
| July 8, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 886876 |
| March 17, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 714733 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
WellSky Corporation
FEI Number
3006129391
Address
11300 Switzer Rd, Overland Park, Kansas 66210, United States
Country
United States
ID: 2aed314b-5fb8-46b5-bc23-9e3c4eda2847