Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3008769961.
Observations4
Issue DateOctober 06, 2011
StatusNo Warning Letter
Related Inspections2
Establishment Details
Firm
Helm Surgical Systems LLC
Location
Greenwood Village, Colorado, United States
FEI Number
3008769961
Product Type
Biologics
Issue Date
October 06, 2011
Country
United States
Inspection History, 2011 to 2012
NAI1
VAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated.
Talk to a Specialist