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Global FDA Facility Graph & Co-Packer Intelligence
Facility Graph → Pharmaceuticals & Sterile/OTC Drugs → Fougera Pharmaceuticals, LLC.
INDEXABLE (PASSES DATA-SUFFICIENCY GATE)
Pharmaceuticals & Sterile/OTC Drugs FEI: 2410271 🛡️ LEVEL 2 · VAI OBSERVATION FOLLOW-UP

Fougera Pharmaceuticals, LLC.

Registered Address: New York, USA (USA)

For Brand Buyers: Fougera Pharmaceuticals, LLC. carries a BBB (76/100) 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: Fougera Pharmaceuticals, LLC.
BBB
76/100
Moderate (VAI)
7-Dim FDA Record Index v2.0
Ranks in the 62th 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 (76/100)
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
49%
483 → Warning Letter Risk
Dim 6 · Brand Contagion
8 Brands
~36 Downstream SKUs
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LAYER 4 · AI BUYER DUE-DILIGENCE INTERVIEW SCRIPT Tailored to FEI 2410271's FDA Record

5 Questions to Ask Fougera Pharmaceuticals, 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 2026-03-26, FDA cited 21 CFR 211.84(d)(2) (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 2026-03-26, FDA cited 21 CFR 211.192 (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?
  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 2410271?
  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 · 2026-03-26
Open Full 483 Analysis & Dossier →

FDA Form 483 issued to Fougera Pharmaceuticals, LLC. (FEI 2410271) on 2026-03-26 following an inspection of its non- sterile manufacturer operations in New York. The report documents 2 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, CAPA, Out-of-Specification (OOS) & Complaint Investigations.

  • 21 CFR 211.84(d)(2) (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. REPEAT OBSERVATION
  • 21 CFR 211.192 (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).

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) 71/100
Materials & Incoming Identity 63/100
Production & Batch Records 78/100
Facilities, Sanitation & Pest 80/100
Laboratory & Stability Controls 77/100
Packaging & Allergen Labeling 81/100
Layer 6 · Clean-Record Sourcing Alternatives

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Score Provenance Receipts

Every point in this facility's FDA Record Index (76/100) is backed by a linked government record (36-month half-life decay).

Event Date Weight Receipt
Inspection Outcome (VAI) 2026-03-26 -8.7 pts INSP-483-2410271-20260326 ↗
Form 483 (2 observations, 1 repeat) 2026-03-26 -7.8 pts 483-2410271-20260326 ↗