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 1000116989.
Observations1
Issue DateMarch 01, 2013
StatusNo Warning Letter
Related Inspections3
Establishment Details
Firm
Helena Laboratories, Inc
Location
Beaumont, Texas, United States
FEI Number
1000116989
Product Type
Devices
Issue Date
March 01, 2013
Country
United States
Inspection History, 2010 to 2017
NAI2
VAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated.