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
FG
GMPGraphv2.0
Global FDA Facility Graph & Co-Packer Intelligence
Facility Graph → Pharmaceuticals & Sterile/OTC Drugs → Macau-Union Pharmaceutical Limited
INDEXABLE (PASSES DATA-SUFFICIENCY GATE)
Pharmaceuticals & Sterile/OTC Drugs FEI: 3011219786 🛡️ LEVEL 2 · VAI OBSERVATION FOLLOW-UP

Macau-Union Pharmaceutical Limited

Registered Address: United States (United States)

For Brand Buyers: Macau-Union Pharmaceutical Limited carries a BBB (72/100) rating due to documented FDA activity centered on Incoming Ingredient Identity Testing & COA Qualification. 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: Macau-Union Pharmaceutical Limited
BBB
72/100
Moderate (VAI)
7-Dim FDA Record Index v2.0
Ranks in the 43th 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
BBB (72/100)
Recency-Weighted Index
Dim 2 · Inspection Shield
Level 2 / 4
Physically Inspected — Documented Form 483 Observations
Dim 4 · 'Elsa' Audit Odds
71%
HIGH PRIORITY TARGET (Next 90–180 Days)
Dim 5 · 180d WL Escalation
61%
483 → Warning Letter Risk
Dim 6 · Brand Contagion
8 Brands
~41 Downstream SKUs
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LAYER 4 · AI BUYER DUE-DILIGENCE INTERVIEW SCRIPT Tailored to FEI 3011219786's FDA Record

5 Questions to Ask Macau-Union Pharmaceutical 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 2025-12-17, FDA cited 21 CFR 211.194(a)(4) (Incoming Ingredient Identity Testing & COA Qualification). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
  2. Q2: On 2025-12-17, FDA cited 21 CFR 212.10 (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 2025-12-17, FDA cited 21 CFR 212.60(g) (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?
  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 3011219786?

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 · 2025-12-17
Open Full 483 Analysis & Dossier →

FDA Form 483 issued to Macau-Union Pharmaceutical Limited (FEI 3011219786) on 2025-12-17 following an inspection of its drug manufacturer operations in United States. The report documents 4 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Personnel GMP Training, Gowning & Hygienic Practices.

  • 21 CFR 211.194(a)(4) (Incoming Ingredient Identity Testing & COA Qualification): Failure to perform at least one test to verify the identity of every incoming dietary ingredient or raw component before use, or relying on a supplier's Certificate of Analysis (COA) without first qualifying the supplier.
  • 21 CFR 212.10 (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. REPEAT OBSERVATION
  • 21 CFR 212.60(g) (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.
  • FDCA 501(a)(2)(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.

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) 67/100
Materials & Incoming Identity 65/100
Production & Batch Records 74/100
Facilities, Sanitation & Pest 76/100
Laboratory & Stability Controls 65/100
Packaging & Allergen Labeling 77/100
Layer 6 · Clean-Record Sourcing Alternatives

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Score Provenance Receipts

Every point in this facility's FDA Record Index (72/100) is backed by a linked government record (36-month half-life decay).

Event Date Weight Receipt
Inspection Outcome (VAI) 2025-12-17 -8.2 pts INSP-483-3011219786-20251217 ↗
Form 483 (4 observations, 1 repeat) 2025-12-17 -12.2 pts 483-3011219786-20251217 ↗