Centro de Construccion de Cardioestimuladores del Uruguay SAAugust 18, 2022

FDA 483 - Centro de Construccion de Cardioestimuladores del Uruguay SA - August 18, 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 Centro de Construccion de Cardioestimuladores del Uruguay SA

Record Details

An FDA inspection of Centro de Construccion de Cardioestimuladores del Uruguay SA, a contract manufacturer and sterilizer in Montevideo, Uruguay, revealed a significant quality system deficiency. The firm was cited for using test equipment with out-of-date calibration labels for troubleshooting a Class III medical device, indicating a failure to ensure equipment suitability for its intended purpose.

Company: Centro de Construccion de Cardioestimuladores del Uruguay SA
Inspection Date: August 18, 2022
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Stephen C. Smith (Investigator)

Open in Dashboard

ID · 8aef0e2e-4b5a-44c6-82b6-460ba07fbbb4