FDA 483 - QuVa Pharma, Inc. - June 16, 2022

QuVa Pharma, Inc. in Temple, TX, an outsourcing facility, received a Form 483 with four observations related to manufacturing and labeling deficiencies. Issues included unsanitary aseptic processing area floors, use of unvalidated software for BUDs, incomplete master production records, and missing required information on drug product labels. These observations indicate significant concerns regarding facility control, data integrity, and product quality.