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 3012478585.
Observations1
Issue DateOctober 24, 2025
StatusNo Warning Letter
Related Inspections3
Establishment Details
Firm
GRAMERCY EXTREMITY ORTHOPEDICS
Location
Richardson, Texas, United States
FEI Number
3012478585
Product Type
Devices
Issue Date
October 24, 2025
Country
United States
Inspection History, 2018 to 2025
NAI1
VAI2
NAI means No Action Indicated. VAI means Voluntary Action Indicated.
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