Helget Gas Products IncMay 25, 2023

FDA 483 - Helget Gas Products Inc - May 25, 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 Helget Gas Products Inc

Record Details

Helget Gas Products Inc. in Bridgeton, MO, a medical gas manufacturer, was inspected and received a Form 483 with eight observations. The inspection revealed significant deficiencies in quality control, labeling procedures, complaint handling, product testing, employee training, annual reviews, and facility maintenance. Key issues include illegible lot codes, lack of SOPs for label control, and failure to conduct required product testing.

Company: Helget Gas Products Inc
Inspection Date: May 25, 2023
Product Type: Drugs
Office: Division of Human and Animal Food Operations - West II
Person: Michele Perry-Williams (Investigator)

Open in Dashboard

ID · 5812e7cd-de0d-4de2-998a-1a9cb04d4813