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 3004577174.
Observations4
Issue DateDecember 09, 2011
StatusNo Warning Letter
Related Inspections7
Establishment Details
Firm
ARJ Medical, Inc. / Gulf Coast Scientific Inc
Location
Oldsmar, Florida, United States
FEI Number
3004577174
Product Type
Devices
Issue Date
December 09, 2011
Country
United States
Inspection History, 2010 to 2021
NAI3
VAI2
OAI2
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.