Company
United StatesUS BioTek Laboratories, Inc., Shoreline, WA – FDA Inspections
Inspection records and compliance data for US BioTek Laboratories, Inc. in Shoreline, Washington. 1 FDA inspection on record, 1 Form 483, last inspected November 14, 2018.
Company Profile
This profile covers US BioTek Laboratories, Inc. based in Shoreline, Washington, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected November 14, 2018.
Most cited issue areas
- Document review, approval by designated individual1 inspection
- Lack of or inadequate complaint procedures1 inspection
- Lack of Written MDR Procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 14, 2018 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1071744 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
US BioTek Laboratories, Inc.
FEI Number
3004762162
Address
16020 Linden Ave N, Shoreline, Washington 98133, United States
Country
United States
ID: 33da3b18-d1d3-4651-b87b-5ee9faa7f654