KEDPLASMA LLCApril 16, 2026

FDA 483 - KEDPLASMA LLC - April 16, 2026

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore KEDPLASMA LLC

Record Details

An FDA inspection of KEDPLASMA LLC in Cinnaminson, NJ, revealed a significant failure in reporting. The firm did not submit a Biological Product Deviation report after allowing a donor with an unacceptable address to make continuous source plasma donations, and subsequently distributing these units. This indicates a lapse in compliance with regulatory reporting requirements for biological products.

Company: KEDPLASMA LLC
Inspection Date: April 16, 2026
Product Type: Biologics
Office: New Jersey District Office
Person: Kish Bolden

Open in Dashboard

ID · 02acc038-0fce-40fc-bfa7-e2eaa100de0c