Delpharm DijonMay 31, 2024

FDA 483 - Delpharm Dijon - May 31, 2024

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 Delpharm Dijon

Record Details

An FDA inspection of Delpharm Dijon, a sterile drug manufacturer in Quetigny, France, revealed significant deficiencies in their manufacturing processes. Observations included inadequate master production and control records lacking theoretical yield and percentage calculations, and a failure to establish appropriate time limits for production phases to ensure drug product quality.

Company: Delpharm Dijon
Inspection Date: May 31, 2024
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
People: Liya Tang
Jolanna A. Norton (Investigator)

Open in Dashboard

ID · bd526063-dc9f-4688-9ee5-26a0d5bb1f98