Form FDA 483 · Issued 2026-03-26
Fougera Pharmaceuticals, LLC. — FDA Form 483 Analysis
FEI: 2410271 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Non- Sterile Manufacturer) · Lead Investigator: Priya N. Subramanian
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.
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Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · 21 CFR 211.84(d)(2)
Incoming Ingredient Identity Testing & COA Qualification
REPEAT CITATION AT FACILITY
Testing Each Component for Conformity with Specs
Inspector Observation Language: "Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality. Specifically, observed during inspection of Fougera Pharmaceuticals, LLC. on 2026-03-26."
Plain-English Meaning: 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.
Standard CAPA Remediation Path: Establish SOP-QA-004 requiring FTIR/HPLC/organoleptic identity testing on 100% of incoming dietary ingredient lots and annual audit + 3-lot confirmatory testing before relying on any vendor COA.
Observation #2 · 21 CFR 211.192
CAPA, Out-of-Specification (OOS) & Complaint Investigations
FIRST-TIME OBSERVATION
Quality control unit review of records
Inspector Observation Language: "Drug product production and control records, are not [reviewed] [approved] by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. Specifically, observed during inspection of Fougera Pharmaceuticals, LLC. on 2026-03-26."
Plain-English Meaning: 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).
Standard CAPA Remediation Path: Deploy a closed-loop CAPA and OOS investigation SOP requiring root-cause determination within 30 business days, impact assessment on distributed lots, and effectiveness checks.