EmCyte CorporationNovember 15, 2023

FDA 483 - EmCyte Corporation - November 15, 2023

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 EmCyte Corporation

Record Details

EmCyte Corporation in Fort Myers, FL, a manufacturer, received two observations during an FDA inspection. The firm was cited for inadequate documentation of corrective and preventive action activities, specifically regarding the verification of effectiveness without established acceptance criteria. Additionally, their complaint handling procedures lacked established time frames for processing complaints.

Company: EmCyte Corporation
Inspection Date: November 15, 2023
Product Type: Device
Office: Office of Medical Device and Radiological Health Division II
Person: Ronald Ifraimov (investigator)

Open in Dashboard

ID · 4c272d2c-fb39-43db-8948-25a030ea7725