Cambrex Charles City, Inc.May 2, 2022

FDA 483 - Cambrex Charles City, Inc. - May 02, 2022

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 Cambrex Charles City, Inc.

Record Details

Cambrex Charles City, Inc. in Charles City, IA, an API manufacturer, was cited for significant deficiencies in laboratory controls and investigation procedures. The inspection revealed issues with scientifically unsound sampling and testing for microbiological contamination and diethylene glycol, as well as untimely and incomplete investigations into manufacturing deviations. These findings indicate a lack of robust quality control and investigation practices.

Company: Cambrex Charles City, Inc.
Inspection Date: May 2, 2022
Product Type: Drugs
Office: Division of Human and Animal Food Operations - West II
People: Brent M. Dehaan
Lisa L. Flores (Consumer Safety Officer/ Federal Investigator)

Open in Dashboard

ID · 2fd557fc-21d0-48ec-a6ca-112f238f4867