Source: FDA, document on file. FDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3006271438.
Observations13
Issue DateMarch 30, 2022
Status1 Related Warning Letter
Establishment TypeDrug Manufacturer
Related Inspections10
Establishment Details
Firm
Novel Laboratories, Inc. d.b.a Lupin Somerset
Location
Somerset, New Jersey, United States
FEI Number
3006271438
Establishment Type
Drug Manufacturer
Product Type
Drugs
Issue Date
March 30, 2022
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.
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