Agora EdgeDecember 14, 2022

FDA 483 - Agora Edge - December 14, 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 Agora Edge

Record Details

An FDA inspection of Agora Edge, a contract manufacturer in Saint Petersburg, FL, revealed a significant deficiency in their quality system. The firm failed to adequately establish procedures for the acceptance of raw materials from suppliers. This indicates a moderate concern regarding the control of incoming materials used in manufacturing.

Company: Agora Edge
Inspection Date: December 14, 2022
Product Type: Other
Office: Office of Medical Device and Radiological Health Division II
Person: Gisselle I. Sensebe

Open in Dashboard

ID · 15466036-37a2-4dda-bd38-1ac5c00ad6d2