South Galveston News

MediSource Partners, LLC in Dallas, Texas was inspected by the Food and Drug Administration (FDA) on July 25 for human cellular, tissue, and gene therapies and received five citations, according to data posted on the FDA’s official website.

The FDA website indicates that the citations were delivered to the company as follows:

'Procedures appropriate to meet core CGTP requirements for all steps that you perform in the manufacture of HCT/Ps were not established, maintained, defined, documented and implemented.'

'Current standard procedures adopted from another organization were not verified to be consistent with the requirements of the CGTP regulations and not appropriate for your operations.'

'Storage temperatures of HCT/Ps were not recorded and maintained.'

'HCT/Ps are not tracked.'

'Procedures for the review, evaluation, documentation and investigation of complaints relating to core CGTP requirements were not established, maintained, defined, documented and implemented.'

The FDA routinely inspects facilities across the nation to determine if the workplaces 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.