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 → Fresenius Kabi USA, LLC
INDEXABLE (PASSES DATA-SUFFICIENCY GATE)
Pharmaceuticals & Sterile/OTC Drugs FEI: 3001833549 🛡️ LEVEL 2 · VAI OBSERVATION FOLLOW-UP

Fresenius Kabi USA, LLC

Registered Address: New York, USA (USA)

For Brand Buyers: Fresenius Kabi USA, LLC carries a BBB (70/100) 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: Fresenius Kabi USA, LLC
BBB
70/100
Moderate (VAI)
7-Dim FDA Record Index v2.0
Ranks in the 36th 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 (70/100)
Recency-Weighted Index
Dim 2 · Inspection Shield
Level 2 / 4
Physically Inspected — Documented Form 483 Observations
Dim 4 · 'Elsa' Audit Odds
68%
MODERATE CYCLE WINDOW (6–12 Months)
Dim 5 · 180d WL Escalation
30%
483 → Warning Letter Risk
Dim 6 · Brand Contagion
4 Brands
~22 Downstream SKUs
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LAYER 4 · AI BUYER DUE-DILIGENCE INTERVIEW SCRIPT Tailored to FEI 3001833549's FDA Record

5 Questions to Ask Fresenius Kabi USA, LLC 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 2026-05-14, FDA cited 21 CFR 211.192 (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 2026-05-14, FDA cited 21 CFR 211.42(c)(10)(v) (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?
  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 3001833549?
  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 · 2026-05-14
Open Full 483 Analysis & Dossier →

FDA Form 483 issued to Fresenius Kabi USA, LLC (FEI 3001833549) on 2026-05-14 following an inspection of its sterile drug manufacturer operations in New York. The report documents 2 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Cleaning Validation, Sanitation Logs & Pest Control.

  • 21 CFR 211.192 (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 211.42(c)(10)(v) (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-2026-88106) · 2026-07-19
Port: Newark / NY, NJ · Charge: UNAPPROVED NEW DRUG / UNDECLARED INGREDIENT (FD&C Act 505(a))
The article appears to be a new drug without an approved New Drug Application (NDA) or ANDA.

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) 73/100
Materials & Incoming Identity 63/100
Production & Batch Records 72/100
Facilities, Sanitation & Pest 66/100
Laboratory & Stability Controls 71/100
Packaging & Allergen Labeling 75/100
Layer 6 · Clean-Record Sourcing Alternatives

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Score Provenance Receipts

Every point in this facility's FDA Record Index (70/100) is backed by a linked government record (36-month half-life decay).

Event Date Weight Receipt
Inspection Outcome (VAI) 2026-05-14 -9.0 pts INSP-483-3001833549-20260514 ↗
Form 483 (2 observations, 0 repeat) 2026-05-14 -5.4 pts 483-3001833549-20260514 ↗
Import Refusal (UNAPPROVED NEW DRUG / UNDECLARED INGREDIENT) 2026-07-19 -7.5 pts OASIS-2026-88106 ↗