Moss Tubes Inc.August 13, 2021

FDA 483 - Moss Tubes Inc. - August 13, 2021

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 Moss Tubes Inc.

Record Details

An FDA inspection of Moss Tubes Inc., a medical device manufacturer in Castleton On Hudson, NY, revealed two significant issues related to quality system documentation. The firm failed to adequately maintain device history records, specifically lacking traceability for sterility test reports, and did not properly document design validation results in the design history file.

Company: Moss Tubes Inc.
Inspection Date: August 13, 2021
Product Type: Device
Office: Division of Human and Animal Food Operations - East I
Person: Kwong P. Lee (investigator)

Open in Dashboard

ID · 946b3ee8-56b0-4d64-82e4-c345e522201f