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 3005735989.
Observations3
Issue DateAugust 09, 2011
StatusNo Warning Letter
Related Inspections4
Establishment Details
Firm
Monarch Labs, LLC
Location
Irvine, California, United States
FEI Number
3005735989
Product Type
Devices
Issue Date
August 09, 2011
Country
United States
Inspection History, 2010 to 2022
NAI2
VAI1
OAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.