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GMPGraphv2.0
Global FDA Facility Graph & Co-Packer Intelligence
Facility Graph → Pharmaceuticals & Sterile/OTC Drugs → Novel Laboratories, Inc. d.b.a Lupin Somerset
INDEXABLE (PASSES DATA-SUFFICIENCY GATE)
Pharmaceuticals & Sterile/OTC Drugs FEI: 3006271438 🛡️ LEVEL 2 · VAI OBSERVATION FOLLOW-UP

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

Registered Address: New Jersey, USA (USA)

For Brand Buyers: Novel Laboratories, Inc. d.b.a Lupin Somerset carries a BB (65/100) rating due to documented FDA activity centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention. Before wiring a deposit, require written proof of CAPA closure and third-party ISO 17025 finished-batch release testing.
Connected FDA Sources (2): FDA ORA FOIA Electronic Reading Room, FDA OASIS Import Refusals · Resolved Name Aliases: Novel Laboratories, Inc. d.b.a Lupin Somerset
BB
65/100
Moderate (VAI)
7-Dim FDA Record Index v2.0
Ranks in the 13th percentile among Pharmaceuticals & Sterile/OTC Drugs facilities.
Based strictly on public U.S. FDA records as of 2026-11-03. See Formula v2.0
Dim 1 · Credit Grade
BB (65/100)
Recency-Weighted Index
Dim 2 · Inspection Shield
Level 2 / 4
Physically Inspected — Documented Form 483 Observations
Dim 4 · 'Elsa' Audit Odds
70%
HIGH PRIORITY TARGET (Next 90–180 Days)
Dim 5 · 180d WL Escalation
55%
483 → Warning Letter Risk
Dim 6 · Brand Contagion
11 Brands
~44 Downstream SKUs
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LAYER 4 · AI BUYER DUE-DILIGENCE INTERVIEW SCRIPT Tailored to FEI 3006271438's FDA Record

5 Questions to Ask Novel Laboratories, Inc. d.b.a Lupin Somerset Before Signing a Manufacturing Contract

Bring these exact questions to your discovery call with their QA Director or account rep before wiring a production deposit:

  1. Q1: On 2026-04-17, FDA cited 21 CFR 211.194(a) (Finished Product Testing, Stability & Expiration Dating). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
  2. Q2: On 2026-04-17, FDA cited 21 CFR 212.20(e) (Electronic Record Data Integrity (21 CFR Part 11) & Retention). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
  3. Q3: On 2026-04-17, FDA cited 21 CFR 211.22(a) (Electronic Record Data Integrity (21 CFR Part 11) & Retention). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
  4. Q4: Do you perform 100% FTIR/HPLC identity testing on incoming active ingredients in-house (21 CFR 111.75(a)(1)), or do you rely on vendor COAs?
  5. Q5: Will you sign our Quality Agreement Rider requiring 24-hour notification if an FDA investigator issues a Form 482 or Form 483 at FEI 3006271438?

Cross-Database Regulatory & Inspection Timeline

Unified chronological history across FDA ORA Inspections, Form 483s, Warning Letters, Enforcement Recalls, and OASIS Import Refusals.

Form FDA 483 Issued · 2026-04-17
Open Full 483 Analysis & Dossier →

FDA Form 483 issued to Novel Laboratories, Inc. d.b.a Lupin Somerset (FEI 3006271438) on 2026-04-17 following an inspection of its drug manufacturer operations in New Jersey. The report documents 3 inspection observations centered on Finished Product Testing, Stability & Expiration Dating, Electronic Record Data Integrity (21 CFR Part 11) & Retention.

  • 21 CFR 211.194(a) (Finished Product Testing, Stability & Expiration Dating): Releasing finished batches without verifying strength/potency/microbiological specs, or placing an expiration/best-by date on labels without supporting real-time or accelerated stability data. REPEAT OBSERVATION
  • 21 CFR 212.20(e) (Electronic Record Data Integrity (21 CFR Part 11) & Retention): Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window.
  • 21 CFR 211.22(a) (Electronic Record Data Integrity (21 CFR Part 11) & Retention): Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window.
OASIS Border Import Refusal (OASIS-2026-88116) · 2026-08-19
Port: Newark / NY, NJ · Charge: UNAPPROVED NEW DRUG / UNDECLARED INGREDIENT (FD&C Act 505(a))
The article appears to be a new drug without an approved New Drug Application (NDA) or ANDA.

Manufacturer Right-of-Reply & Free Match Correction

GUARDRAIL PROTECTED

To ensure fairness and accuracy, facility owners may submit verified Form 483 closeout evidence, CAPA completion statements, or entity-resolution corrections free of charge. Sponsorship never alters an FDA Record Index score.

Dimension 3 · FDA 6-System Model

6-Subsystem cGMP Radar Breakdown

Sub-scores mapped across FDA's six core inspection subsystems.

Quality System (CAPA & OOS) 52/100
Materials & Incoming Identity 66/100
Production & Batch Records 67/100
Facilities, Sanitation & Pest 69/100
Laboratory & Stability Controls 52/100
Packaging & Allergen Labeling 70/100
Layer 6 · Clean-Record Sourcing Alternatives

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Score Provenance Receipts

Every point in this facility's FDA Record Index (65/100) is backed by a linked government record (36-month half-life decay).

Event Date Weight Receipt
Inspection Outcome (VAI) 2026-04-17 -8.8 pts INSP-483-3006271438-20260417 ↗
Form 483 (3 observations, 1 repeat) 2026-04-17 -10.6 pts 483-3006271438-20260417 ↗
Import Refusal (UNAPPROVED NEW DRUG / UNDECLARED INGREDIENT) 2026-08-19 -7.6 pts OASIS-2026-88116 ↗