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 → Fujifilm Diosynth Biotechnologies USA Inc.
INDEXABLE (PASSES DATA-SUFFICIENCY GATE)
Pharmaceuticals & Sterile/OTC Drugs FEI: 3000718852 🛡️ LEVEL 2 · VAI OBSERVATION FOLLOW-UP

Fujifilm Diosynth Biotechnologies USA Inc.

Registered Address: North Carolina, USA (USA)

For Brand Buyers: Fujifilm Diosynth Biotechnologies USA Inc. carries a BBB (71/100) 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 (2): FDA ORA FOIA Electronic Reading Room, FDA OASIS Import Refusals · Resolved Name Aliases: Fujifilm Diosynth Biotechnologies USA Inc.
BBB
71/100
Moderate (VAI)
7-Dim FDA Record Index v2.0
Ranks in the 40th 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 (71/100)
Recency-Weighted Index
Dim 2 · Inspection Shield
Level 2 / 4
Physically Inspected — Documented Form 483 Observations
Dim 4 · 'Elsa' Audit Odds
77%
HIGH PRIORITY TARGET (Next 90–180 Days)
Dim 5 · 180d WL Escalation
30%
483 → Warning Letter Risk
Dim 6 · Brand Contagion
9 Brands
~43 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 3000718852's FDA Record

5 Questions to Ask Fujifilm Diosynth Biotechnologies USA Inc. 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 2026-03-27, FDA cited 21 CFR 211.84(d)(1) (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 2026-03-27, FDA cited 21 CFR 211.68(b) (Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems). 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 3000718852?
  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 · 2026-03-27
Open Full 483 Analysis & Dossier →

FDA Form 483 issued to Fujifilm Diosynth Biotechnologies USA Inc. (FEI 3000718852) on 2026-03-27 following an inspection of its drug substance manufacturer operations in North Carolina. The report documents 2 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems.

  • 21 CFR 211.84(d)(1) (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 211.68(b) (Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems): Scales, thermometers, pH meters, autoclaves, or purified water systems lacking current NIST-traceable calibration or process validation.
OASIS Border Import Refusal (OASIS-2026-88119) · 2026-02-19
Port: Miami, FL · Charge: DEVICE LACKS 510(K) CLEARANCE (FD&C Act 510(k))
The medical device appears to lack required premarket notification 510(k) clearance or establishment registration.

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) 74/100
Materials & Incoming Identity 64/100
Production & Batch Records 73/100
Facilities, Sanitation & Pest 67/100
Laboratory & Stability Controls 72/100
Packaging & Allergen Labeling 76/100
Layer 6 · Clean-Record Sourcing Alternatives

Verified AAA/AA Co-Packers in This Sector

Compare or request quotes from top-rated contract manufacturers with clean FDA inspection histories:

Lone Star Nutraceuticals & Gummy Works LLC (TX)
Grade AAA · 99/100 Clean Record
Get Quote →
Get Quote →
Get Quote →

Score Provenance Receipts

Every point in this facility's FDA Record Index (71/100) is backed by a linked government record (36-month half-life decay).

Event Date Weight Receipt
Inspection Outcome (VAI) 2026-03-27 -8.7 pts INSP-483-3000718852-20260327 ↗
Form 483 (2 observations, 0 repeat) 2026-03-27 -5.2 pts 483-3000718852-20260327 ↗
Import Refusal (DEVICE LACKS 510(K) CLEARANCE) 2026-02-19 -6.8 pts OASIS-2026-88119 ↗