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 3006271438.
Observations4
Issue DateFebruary 23, 2018
Status1 Related Warning Letter
Related Inspections10
Establishment Details
Firm
Novel Laboratories, Inc. d.b.a Lupin Somerset
Location
Somerset, New Jersey, United States
FEI Number
3006271438
Product Type
Drugs
Issue Date
February 23, 2018
Country
United States
Inspection History, 2017 to 2026
NAI2
VAI7
OAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.