Patheon Italia S.p.A.May 26, 2023

FDA 483 - Patheon Italia S.p.A. - May 26, 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 Patheon Italia S.p.A.

Record Details

An FDA inspection of Patheon Italia S.p.A. in Monza, Italy, a sterile drug manufacturer, revealed significant deficiencies across multiple areas. Observations included inadequate environmental monitoring in aseptic processing, scientifically unjustified media fill designs for sterile products, and improperly qualified equipment. Additionally, the firm's warehouse lacked scientifically-driven temperature mapping studies for drug product storage.

Company: Patheon Italia S.p.A.
Inspection Date: May 26, 2023
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
People: Brandy N. Lepage (Consumer Safety Officer)
Mindy M. Chou

Open in Dashboard

ID · 79cf157f-fd82-4b03-8b1c-6b688732e007