Medline Industries, IncJuly 10, 2023

FDA 483 - Medline Industries, Inc - July 10, 2023

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 Medline Industries, Inc

Record Details

An FDA inspection of Medline Industries, LP in Mundelein, IL, a control testing laboratory for drugs, revealed two significant observations. The firm was cited for inadequate written records of investigations into unexplained discrepancies and for a stability program that does not assure drug product testing in its marketed container-closure system. These issues suggest deficiencies in quality control and product stability assurance.

Company: Medline Industries, Inc
Inspection Date: July 10, 2023
Product Type: Drugs
Office: Division of Human and Animal Food Operations - East VI
People: Anders Evenson
Michele L. Glendenning

Open in Dashboard

ID · 8fb77147-1fb8-43f9-ae51-a05672645c59