CC0 PUBLIC RECORD GRAPH Every score & timeline item links directly to its underlying U.S. FDA record (openFDA, ORA FOIA Reading Room, DECRS & OASIS).
Scoring Formula v2.0 & Legal Guardrails REST API v1
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GMPGraphv2.0
Global FDA Facility Graph & Co-Packer Intelligence
Facility Graph → Pharmaceuticals & Sterile/OTC Drugs → Jiangsu Hansoh Pharmaceutical Group Co Ltd.
INDEXABLE (PASSES DATA-SUFFICIENCY GATE)
Pharmaceuticals & Sterile/OTC Drugs FEI: 3008316144 🛡️ LEVEL 2 · VAI OBSERVATION FOLLOW-UP

Jiangsu Hansoh Pharmaceutical Group Co Ltd.

Registered Address: China (China)

For Brand Buyers: Jiangsu Hansoh Pharmaceutical Group Co Ltd. carries a BB (68/100) rating due to documented FDA activity centered on CAPA, Out-of-Specification (OOS) & Complaint Investigations. 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: Jiangsu Hansoh Pharmaceutical Group Co Ltd.
BB
68/100
Moderate (VAI)
7-Dim FDA Record Index v2.0
Ranks in the 25th 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 (68/100)
Recency-Weighted Index
Dim 2 · Inspection Shield
Level 2 / 4
Physically Inspected — Documented Form 483 Observations
Dim 4 · 'Elsa' Audit Odds
80%
HIGH PRIORITY TARGET (Next 90–180 Days)
Dim 5 · 180d WL Escalation
36%
483 → Warning Letter Risk
Dim 6 · Brand Contagion
7 Brands
~35 Downstream SKUs
🛡️ Run AI Mock Inspection on This Plant ⚖️ Compare Side-by-Side vs. Clean Co-Packers 📄 Request EIR via FOIA
Represent this facility? Claim profile or post 483 closeout response (Free)
LAYER 4 · AI BUYER DUE-DILIGENCE INTERVIEW SCRIPT Tailored to FEI 3008316144's FDA Record

5 Questions to Ask Jiangsu Hansoh Pharmaceutical Group Co Ltd. 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 2026-04-24, 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?
  2. Q2: On 2026-04-24, FDA cited 21 CFR 211.25(a) (Personnel GMP Training, Gowning & Hygienic Practices). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
  3. Q3: On 2026-04-24, FDA cited 21 CFR 211.42(a) (Cleaning Validation, Sanitation Logs & Pest Control). 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 3008316144?

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 · 2026-04-24
Open Full 483 Analysis & Dossier →

FDA Form 483 issued to Jiangsu Hansoh Pharmaceutical Group Co Ltd. (FEI 3008316144) on 2026-04-24 following an inspection of its sterile drug manufacturer operations in China. The report documents 3 inspection observations centered on CAPA, Out-of-Specification (OOS) & Complaint Investigations, Personnel GMP Training, Gowning & Hygienic Practices.

  • 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-2026-88113) · 2026-05-19
Port: Savannah, GA · Charge: MISBRANDED COSMETIC / COLOR ADDITIVE (FD&C Act 601(e))
The cosmetic product appears to bear or contain an unlisted color additive or lacks mandatory MoCRA responsible person labeling.

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) 63/100
Materials & Incoming Identity 69/100
Production & Batch Records 70/100
Facilities, Sanitation & Pest 64/100
Laboratory & Stability Controls 69/100
Packaging & Allergen Labeling 73/100
Layer 6 · Clean-Record Sourcing Alternatives

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Grade AAA · 99/100 Clean Record
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Score Provenance Receipts

Every point in this facility's FDA Record Index (68/100) is backed by a linked government record (36-month half-life decay).

Event Date Weight Receipt
Inspection Outcome (VAI) 2026-04-24 -8.9 pts INSP-483-3008316144-20260424 ↗
Form 483 (3 observations, 0 repeat) 2026-04-24 -8.0 pts 483-3008316144-20260424 ↗
Import Refusal (MISBRANDED COSMETIC / COLOR ADDITIVE) 2026-05-19 -7.2 pts OASIS-2026-88113 ↗