RAM Scientific, Inc. – FDA 483, Jun 1, 2021

RAM Scientific, Inc. in Nashville, TN, a repackager/relabeler, received an FDA Form 483 citing three observations. The firm failed to maintain adequate records for a recall action, lacked properly established procedures for the control and disposition of nonconforming products, and exhibited insufficient documentation of corrective and preventive action activities. These findings indicate deficiencies in the firm's quality system.