Form FDA 483 · Issued 2025-12-16
KEDPLASMA LLC — FDA Form 483 Analysis
FEI: 3024967183 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Source Plasma Establishment) · Lead Investigator: Priya N. Subramanian
FDA Form 483 issued to KEDPLASMA LLC (FEI 3024967183) on 2025-12-16 following an inspection of its source plasma establishment operations in Indiana. The report documents 2 inspection observations centered on Personnel GMP Training, Gowning & Hygienic Practices, CAPA, Out-of-Specification (OOS) & Complaint Investigations.
Get Full Annotated 483 Dossier + CAPA Checklist
Instant PDF + CFR Matrix ($79 vs. Redica's $289)
Need Help Fixing These 2 Citations?
Get matched with a vetted 21 CFR remediation consultant
Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · 21 CFR 212.10
Personnel GMP Training, Gowning & Hygienic Practices
FIRST-TIME OBSERVATION
Lack Adequate Resources, Facilities, Equipment.
Inspector Observation Language: "You lack adequate [resources] [facilities] [equipment] to enable your personnel to perform their functions. Specifically, observed during inspection of KEDPLASMA LLC on 2025-12-16."
Plain-English Meaning: Operators performing manufacturing or QA tasks without documented GMP/SOP training, or observed gowning/hygiene deviations in production rooms.
Standard CAPA Remediation Path: Maintain role-based SOP training matrices signed prior to independent floor assignment and annual cGMP refresher assessments.
Observation #2 · 21 CFR 212.60(e)
CAPA, Out-of-Specification (OOS) & Complaint Investigations
FIRST-TIME OBSERVATION
Equipment
Inspector Observation Language: "All equipment used to perform the testing is not [suitable for its intended purposes] [capable of producing valid results]. Specifically,observed during inspection of KEDPLASMA LLC on 2025-12-16."
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.