CC0 PUBLIC RECORD GRAPH Every score & timeline item links directly to its underlying U.S. FDA record (openFDA, ORA FOIA Reading Room, DECRS & OASIS).
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GMPGraphv2.0
Global FDA Facility Graph & Co-Packer Intelligence
Facility Graph → Pharmaceuticals & Sterile/OTC Drugs → Zydus Lifesciences Limited
INDEXABLE (PASSES DATA-SUFFICIENCY GATE)
Pharmaceuticals & Sterile/OTC Drugs FEI: 3012977526 🛡️ LEVEL 2 · VAI OBSERVATION FOLLOW-UP

Zydus Lifesciences Limited

Registered Address: India (India)

For Brand Buyers: Zydus Lifesciences Limited carries a BB (60/100) rating due to documented FDA activity centered on Finished Product Testing, Stability & Expiration Dating. 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: Zydus Lifesciences Limited
BB
60/100
Elevated Citations
7-Dim FDA Record Index v2.0
More recent FDA citations than 89% 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
BB (60/100)
Recency-Weighted Index
Dim 2 · Inspection Shield
Level 2 / 4
Physically Inspected — Documented Form 483 Observations
Dim 4 · 'Elsa' Audit Odds
75%
HIGH PRIORITY TARGET (Next 90–180 Days)
Dim 5 · 180d WL Escalation
67%
483 → Warning Letter Risk
Dim 6 · Brand Contagion
11 Brands
~46 Downstream SKUs
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LAYER 4 · AI BUYER DUE-DILIGENCE INTERVIEW SCRIPT Tailored to FEI 3012977526's FDA Record

5 Questions to Ask Zydus Lifesciences 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 2026-05-05, FDA cited 21 CFR 211.160(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 2026-05-05, FDA cited 21 CFR 211.188(b) (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 2026-05-05, FDA cited 21 CFR 211.198(a) (CAPA, Out-of-Specification (OOS) & Complaint Investigations). 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 3012977526?

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 · 2026-05-05
Open Full 483 Analysis & Dossier →

FDA Form 483 issued to Zydus Lifesciences Limited (FEI 3012977526) on 2026-05-05 following an inspection of its sterile manufacturer operations in India. The report documents 5 inspection observations centered on Finished Product Testing, Stability & Expiration Dating, Master Manufacturing & Batch Production Records (MMR/BPR).

  • 21 CFR 211.160(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 211.188(b) (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 211.198(a) (CAPA, Out-of-Specification (OOS) & Complaint Investigations): Failure to thoroughly investigate unexplained batch discrepancies, Out-of-Specification lab results, or consumer complaints/adverse events and document root-cause Corrective and Preventive Actions (CAPA).
  • 21 CFR 211.25(a) (Personnel GMP Training, Gowning & Hygienic Practices): Operators performing manufacturing or QA tasks without documented GMP/SOP training, or observed gowning/hygiene deviations in production rooms.
  • 21 CFR 211.42(a) (Cleaning Validation, Sanitation Logs & Pest Control): Incomplete equipment cleaning/sanitation logs, inadequate allergen or cross-contamination changeover validation, or gaps in facility pest exclusion.
OASIS Border Import Refusal (OASIS-2026-88110) · 2026-02-19
Port: Los Angeles / Long Beach, CA · Charge: FILTH / INSANITARY CONDITIONS (FD&C Act 402(a)(4))
The article appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth.

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) 55/100
Materials & Incoming Identity 61/100
Production & Batch Records 54/100
Facilities, Sanitation & Pest 56/100
Laboratory & Stability Controls 47/100
Packaging & Allergen Labeling 65/100
Layer 6 · Clean-Record Sourcing Alternatives

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Score Provenance Receipts

Every point in this facility's FDA Record Index (60/100) is backed by a linked government record (36-month half-life decay).

Event Date Weight Receipt
Inspection Outcome (VAI) 2026-05-05 -8.9 pts INSP-483-3012977526-20260505 ↗
Form 483 (5 observations, 1 repeat) 2026-05-05 -16.0 pts 483-3012977526-20260505 ↗
Import Refusal (FILTH / INSANITARY CONDITIONS) 2026-02-19 -6.8 pts OASIS-2026-88110 ↗