Company
United StatesBolder Surgical, LLC, Louisville, CO – FDA Inspections
Inspection records and compliance data for Bolder Surgical, LLC in Louisville, Colorado. 3 FDA inspections on record, 1 Form 483, last inspected December 14, 2022.
Company Profile
This profile covers Bolder Surgical, LLC based in Louisville, Colorado, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 0
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected December 18, 2014. Last inspected December 14, 2022.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Lack of or inadequate procedures1 inspection
- Lack of or inadequate procedures - Acceptance activities1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 14, 2022 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1194205 |
| November 27, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1032115 |
| December 18, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 907576 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Bolder Surgical, LLC
FEI Number
3010377594
Address
331 S 104th St Ste 200, Louisville, Colorado 80027, United States
Country
United States
ID: ebf174ab-a846-429d-b573-ea18c0e9b772