Novel Laboratories, Inc. d.b.a Lupin Somerset

Form 483

Somerset, New JerseyFEI 3006271438Issued October 10, 2025

View FDA's Record for This Firm

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.

Observations1

Issue DateOctober 10, 2025

Status1 Related Warning Letter

Related Inspections10

Establishment Details

Firm: Novel Laboratories, Inc. d.b.a Lupin Somerset
Location: Somerset, New Jersey
FEI Number: 3006271438
Product Type: Devices
Issue Date: October 10, 2025
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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Novel Laboratories, Inc. d.b.a Lupin Somerset FDA Form 483, Somerset, New Jersey, October 10, 2025