Harmac Medical Products, Inc.February 11, 2022

FDA 483 - Harmac Medical Products, Inc. - February 11, 2022

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Record Details

An FDA inspection of Harmac Medical Products, Inc. in Buffalo, NY, a medical device contract manufacturer, identified two significant observations. The firm was cited for inadequate procedures regarding the verification and validation of corrective and preventive actions. Additionally, software used in production for dimensional analysis of components was found to be unvalidated for its intended use.

Company: Harmac Medical Products, Inc.
Inspection Date: February 11, 2022
Product Type: Device
Office: Division of Human and Animal Food Operations - East I
Person: Matthew D. Schnittker

Open in Dashboard

ID · 557e2b54-654a-449b-95e8-31f8f1af312e