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Facility Graph → Pharmaceuticals & Sterile/OTC Drugs → Lupin Limited
INDEXABLE (PASSES DATA-SUFFICIENCY GATE)
Pharmaceuticals & Sterile/OTC Drugs FEI: 3004819820 🛡️ LEVEL 2 · VAI OBSERVATION FOLLOW-UP

Lupin Limited

Registered Address: India (India)

For Brand Buyers: Lupin Limited carries a CCC (55/100) 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 (1): FDA ORA FOIA Electronic Reading Room · Resolved Name Aliases: Lupin Limited
CCC
55/100
Elevated Citations
7-Dim FDA Record Index v2.0
More recent FDA citations than 92% of tracked 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
CCC (55/100)
Recency-Weighted Index
Dim 2 · Inspection Shield
Level 2 / 4
Physically Inspected — Documented Form 483 Observations
Dim 4 · 'Elsa' Audit Odds
76%
HIGH PRIORITY TARGET (Next 90–180 Days)
Dim 5 · 180d WL Escalation
85%
483 → Warning Letter Risk
Dim 6 · Brand Contagion
9 Brands
~42 Downstream SKUs
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LAYER 4 · AI BUYER DUE-DILIGENCE INTERVIEW SCRIPT Tailored to FEI 3004819820's FDA Record

5 Questions to Ask Lupin Limited 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 2025-11-21, FDA cited 21 CFR 211.42(c)(7) (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?
  2. Q2: On 2025-11-21, FDA cited 21 CFR 211.130(c) (Master Manufacturing & Batch Production Records (MMR/BPR)). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
  3. Q3: On 2025-11-21, FDA cited 21 CFR 211.134(a) (Label Control, Undeclared Allergens & Structure/Function Claims). 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 3004819820?

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 · 2025-11-21
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FDA Form 483 issued to Lupin Limited (FEI 3004819820) on 2025-11-21 following an inspection of its drug manufacturer operations in India. The report documents 3 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention, Master Manufacturing & Batch Production Records (MMR/BPR).

  • 21 CFR 211.42(c)(7) (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 211.130(c) (Master Manufacturing & Batch Production Records (MMR/BPR)): Missing Master Manufacturing Records (MMRs) or incomplete Batch Production Records (BPRs) lacking exact component weights, lot numbers, yield reconciliation, or second-person verification.
  • 21 CFR 211.134(a) (Label Control, Undeclared Allergens & Structure/Function Claims): Undeclared major food allergens (milk, soy, wheat, tree nuts, peanuts, egg, sesame), label mix-ups at the packaging line, or unauthorized disease treatment claims.
Form FDA 483 Issued · 2025-09-16
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FDA Form 483 issued to Lupin Limited (FEI 3004819820) on 2025-09-16 following an inspection of its sterile drug manufacturer operations in India. The report documents 5 inspection observations centered on Finished Product Testing, Stability & Expiration Dating.

  • 21 CFR 211.170(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.
  • 21 CFR 211.110(b) (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.
  • 21 CFR 211.150(b) (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 211.160(b)(3) (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.
  • 21 CFR 211.170(b) (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. REPEAT OBSERVATION

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) 28/100
Materials & Incoming Identity 56/100
Production & Batch Records 49/100
Facilities, Sanitation & Pest 59/100
Laboratory & Stability Controls 32/100
Packaging & Allergen Labeling 52/100
Layer 6 · Clean-Record Sourcing Alternatives

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Score Provenance Receipts

Every point in this facility's FDA Record Index (55/100) is backed by a linked government record (36-month half-life decay).

Event Date Weight Receipt
Inspection Outcome (VAI) 2025-11-21 -8.0 pts INSP-483-3004819820-20251121 ↗
Inspection Outcome (VAI) 2025-09-16 -7.7 pts INSP-483-3015392060-20250916 ↗
Form 483 (3 observations, 0 repeat) 2025-11-21 -7.2 pts 483-3004819820-20251121 ↗
Form 483 (5 observations, 1 repeat) 2025-09-16 -13.9 pts 483-3015392060-20250916 ↗