Slater Endoscopy, LLCFebruary 2, 2023

FDA 483 - Slater Endoscopy, LLC - February 02, 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 Slater Endoscopy, LLC

Record Details

Slater Endoscopy, LLC, a medical device manufacturer in Miramar, FL, was inspected by the FDA from January 31 to February 2, 2023. The inspection revealed a deficiency in document control procedures, specifically regarding the updating of Design History Files and Device Master Records after material and process changes. This indicates a moderate compliance issue related to quality system documentation.

Company: Slater Endoscopy, LLC
Inspection Date: February 2, 2023
Product Type: Device
Office: Office of Medical Device and Radiological Health Division II
Person: Dianiris C. Ayala

Open in Dashboard

ID · 5a508b1e-f87c-4f42-ae17-0ae627f77172