Source: FDA record for this establishment. FDA publishes inspections or enforcement actions for this establishment, listed further down this page, but we have not matched this particular Form 483 to a document or an inspection date FDA has released. It stays out of the default view for that reason. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3006271438.
Observations13
Issue DateAugust 26, 2013
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
August 26, 2013
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.