Englewood Lab Korea Co., Ltd.October 25, 2024

FDA 483 - Englewood Lab Korea Co., Ltd. - October 25, 2024

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 Englewood Lab Korea Co., Ltd.

Record Details

An FDA inspection of Englewood Lab Korea Co., Ltd., an OTC pharmaceutical manufacturer, revealed three significant observations. These included deficiencies in microbiological testing of components, failure to fully follow quality control unit procedures, and inadequate recording and justification of deviations from production and process control procedures, specifically regarding actions to prevent reoccurrence.

Company: Englewood Lab Korea Co., Ltd.
Inspection Date: October 25, 2024
Product Type: Drugs
Office: Office of Inspections and Investigations
Person: Matthew B. Casale ( Investigator )

Open in Dashboard

ID · 6a134621-bb4b-4ce8-82d1-ddff864c603a