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 → Zhejiang Huahai Pharmaceutical Co., Ltd.
INDEXABLE (PASSES DATA-SUFFICIENCY GATE)
Pharmaceuticals & Sterile/OTC Drugs FEI: 3003999190 🛡️ LEVEL 2 · VAI OBSERVATION FOLLOW-UP

Zhejiang Huahai Pharmaceutical Co., Ltd.

Registered Address: China (China)

For Brand Buyers: Zhejiang Huahai Pharmaceutical 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: Zhejiang Huahai Pharmaceutical 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
79%
HIGH PRIORITY TARGET (Next 90–180 Days)
Dim 5 · 180d WL Escalation
49%
483 → Warning Letter Risk
Dim 6 · Brand Contagion
30 Brands
~126 Downstream SKUs
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VERIFIED CONTRACT MANUFACTURER / CO-PACKER

Co-Packing Capabilities, Minimums & Certifications

Request Quote from Zhejiang Huahai Pharmaceutical Co., Ltd. →

Contract pharmaceuticals & sterile/otc drugs manufacturing in CH.

Minimum Run (MOQ)5,000 units
Typical Turnaround6–10 weeks
In-House Analytical Lab3rd-Party ISO Lab
Turnkey R&D FormulationAvailable
Dosage & Product Formats:
Contract PackagingFormulationBatch Blending
Registrations & Quality Certifications:
FDA Registered Establishment
LAYER 4 · AI BUYER DUE-DILIGENCE INTERVIEW SCRIPT Tailored to FEI 3003999190's FDA Record

5 Questions to Ask Zhejiang Huahai Pharmaceutical 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 211.180(e)(2) (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 211.180(e)(1) (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: 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?
  4. Q4: Will you sign our Quality Agreement Rider requiring 24-hour notification if an FDA investigator issues a Form 482 or Form 483 at FEI 3003999190?
  5. Q5: Can we review a redacted Master Manufacturing Record (MMR) and Batch Production Record (BPR) with dual-operator weight verification and yield reconciliation?

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 Zhejiang Huahai Pharmaceutical Co., Ltd. (FEI 3003999190) on 2026-04-24 following an inspection of its drug manufacturer operations in China. The report documents 2 inspection observations centered on CAPA, Out-of-Specification (OOS) & Complaint Investigations, Master Manufacturing & Batch Production Records (MMR/BPR).

  • 21 CFR 211.180(e)(2) (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). REPEAT OBSERVATION
  • 21 CFR 211.180(e)(1) (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.
OASIS Border Import Refusal (OASIS-2026-88112) · 2026-04-19
Port: Houston, TX · Charge: ADULTERATED DIETARY SUPPLEMENT — CGMP (FD&C Act 402(g)(1))
The dietary supplement appears to have been prepared, packed, or held under conditions that do not meet Dietary Supplement CGMP regulations (21 CFR Part 111).

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) 57/100
Materials & Incoming Identity 69/100
Production & Batch Records 62/100
Facilities, Sanitation & Pest 72/100
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-483-3003999190-20260424 ↗
Form 483 (2 observations, 1 repeat) 2026-04-24 -8.0 pts 483-3003999190-20260424 ↗
Import Refusal (ADULTERATED DIETARY SUPPLEMENT — CGMP) 2026-04-19 -7.1 pts OASIS-2026-88112 ↗