Biomat USA, Inc. – FDA 483, Jul 7, 2021

Biomat USA, Inc. in Wichita Falls, TX, was cited on a Form 483 for failing to follow its written standard operating procedures during an inspection from June 30 to July 7, 2021. The firm implemented a new electronic donor management system without completing a required performance qualification. This oversight resulted in donors donating plasma more frequently than permitted, thereby posing a health risk to the donors.