Elevate SurgicalMarch 4, 2019

FDA 483 - Elevate Surgical - March 04, 2019

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 Elevate Surgical

Record Details

An FDA inspection of Sports Tek Medical Inc. in Honolulu, HI, revealed significant deficiencies in their HCT/P storage and distribution operations. The firm lacked a comprehensive quality program and essential procedures, leading to issues with appropriate storage temperatures for HCT/Ps and inadequate record retention practices. These observations indicate a failure to meet core CGTP requirements.

Company: Elevate Surgical
Inspection Date: March 4, 2019
Product Type: Biologics
Office: Minneapolis District Office
Person: Susan M North

Open in Dashboard

ID · b7267be4-3eec-4849-b1e8-129a649fe43b