Company
United StatesGreat Lakes Orthopedics, LLC, Brookfield, WI – FDA Inspections
Inspection records and compliance data for Great Lakes Orthopedics, LLC in Brookfield, Wisconsin. 5 FDA inspections on record, last inspected July 09, 2018.
Company Profile
This profile covers Great Lakes Orthopedics, LLC based in Brookfield, Wisconsin, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected January 5, 2010. Last inspected July 9, 2018.
Most cited issue areas
- Deviations--Investigation, documenting, trending1 inspection
- Documentation not maintained1 inspection
- Documentation of maintenance and cleaning1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 9, 2018 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1061276 |
| October 23, 2015 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 949097 |
| November 26, 2013 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 857253 |
| October 17, 2011 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 752336 |
| January 5, 2010 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 638727 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Great Lakes Orthopedics, LLC
FEI Number
3003406950
Address
3330 Gateway Rd, Brookfield, Wisconsin 53045, United States
Country
United States
ID: 6c5db852-8aa2-4eb5-abf5-29946e834e82