The inspection covered the following areas:
'Postmarket Assurance: Devices'
The final report indicated that Global Prosthetics, Inc. should take action to correct managing operations in the area of device compliance. No action was required for the other area.
The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly for businesses to consistently make smarter business decisions for the future.
The FDA is a government agency that is primarily responsible for monitoring the manufacturing and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.