Company
United StatesOverlake Reproductive Health Laboratory LLC, Bellevue, WA – FDA Inspections
Inspection records and compliance data for Overlake Reproductive Health Laboratory LLC in Bellevue, Washington. 6 FDA inspections on record, 1 Form 483, last inspected March 23, 2023.
Company Profile
This profile covers Overlake Reproductive Health Laboratory LLC based in Bellevue, Washington, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 3
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected January 5, 2011. Last inspected March 23, 2023.
Most cited issue areas
- Responsible person to determine, document2 inspections
- Accurate, indelible, legible1 inspection
- Determination based on screening and testing1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 23, 2023 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1200992 |
| September 27, 2017 | NAI | Biologics · Blood and Blood Products | 1026748 |
| April 19, 2016 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 967310 |
| December 9, 2014 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 905615 |
| January 17, 2014 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 862534 |
| January 5, 2011 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 706568 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Overlake Reproductive Health Laboratory LLC
FEI Number
3004174071
Address
11232 NE 15th St Ste 201, Bellevue, Washington 98004, United States
Country
United States
ID: 5707864b-3bf4-42f6-9161-696242e83751