Company
United StatesWHK BioSystems, LLC, Clearwater, FL – FDA Inspections
Inspection records and compliance data for WHK BioSystems, LLC in Clearwater, Florida. 1 FDA inspection on record, last inspected June 28, 2014.
Company Profile
This profile covers WHK BioSystems, LLC based in Clearwater, Florida, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
Inspected June 28, 2014.
Most cited issue areas
- Lack of or inadequate process validation1 inspection
- Lack of Written MDR Procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 28, 2014 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 888855 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
WHK BioSystems, LLC
FEI Number
3010473074
Address
11345 53rd St N, Clearwater, Florida 33760, United States
Country
United States
ID: a1de0bc7-1be6-43f5-b66f-6c3e3b967d04