Materialise USA LLCOctober 6, 2021

FDA 483 - Materialise USA LLC - October 06, 2021

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 Materialise USA LLC

Record Details

Materialise USA LLC, a medical device manufacturer in Plymouth, MI, was cited for significant deficiencies in its design control processes during an FDA inspection. The firm failed to adequately establish procedures for design input, design verification, and design plans. Additionally, the risk analysis for its Class III tracheal splints was found to be incomplete.

Company: Materialise USA LLC
Inspection Date: October 6, 2021
Product Type: Device
Office: Division of Pharmaceutical Quality Operations III
Person: Thomas A. Peter (Medical Device Senior Operations Officer at FDA)

Open in Dashboard

ID · f8697b3a-db6a-4c38-8a7f-1fa8a1413723