Kedrion Biopharma Inc.June 25, 2021

FDA 483 - Kedrion Biopharma Inc. - June 25, 2021

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 Kedrion Biopharma Inc.

Record Details

An FDA inspection of Medisca Biopharma Inc. in Melville, NY, an API and Intermediate Manufacturer, revealed significant deficiencies in facility cleanliness and process control. Inspectors observed powdery substances and dried matter on equipment labeled as "clean," indicating inadequate cleaning practices. Furthermore, there was no current assessment of the cleaning process, including microbial control, which could impact product quality.

Company: Kedrion Biopharma Inc.
Inspection Date: June 25, 2021
Product Type: Drugs
Office: Division of Human and Animal Food Operations - East I
People: David Galler-Veezy
C. Eric Thomas (company_representative)
Susan M. Jackson (investigator)
Burnell M. Henry (Investigator)

Open in Dashboard

ID · 35995803-c3d0-4321-b6b6-3f34abdff6af