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 3010377594.
Observations6
Issue DateNovember 27, 2017
StatusNo Warning Letter
Related Inspections3
Establishment Details
Firm
Bolder Surgical, LLC
Location
Louisville, Colorado, United States
FEI Number
3010377594
Product Type
Devices
Issue Date
November 27, 2017
Country
United States
Inspection History, 2014 to 2022
NAI2
VAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated.