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 1000522686.
Observations17
Issue DateAugust 25, 2015
StatusNo Warning Letter
Related Inspections4
Establishment Details
Firm
Gentell, Inc
Location
Bristol, Pennsylvania, United States
FEI Number
1000522686
Product Type
Devices
Issue Date
August 25, 2015
Country
United States
Inspection History, 2015 to 2026
NAI2
VAI1
OAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.