Company
United StatesHelm Surgical Systems LLC, Greenwood Village, CO – FDA Inspections
Inspection records and compliance data for Helm Surgical Systems LLC in Greenwood Village, Colorado. 2 FDA inspections on record, last inspected October 26, 2012.
Company Profile
This profile covers Helm Surgical Systems LLC based in Greenwood Village, Colorado, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected October 6, 2011. Last inspected October 26, 2012.
Most cited issue areas
- All core requirements covered in program1 inspection
- Documentation/approval prior to implementation1 inspection
- Procedures to meet core CTGP1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 26, 2012 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 805131 |
| October 6, 2011 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 748995 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Helm Surgical Systems LLC
FEI Number
3008769961
Address
5350 Dtc Pkwy Ste 204, Greenwood Village, Colorado 80111, United States
Country
United States
ID: e36ddae9-b0f5-4513-8654-0c38acb3e6d4