FDA 483 - Scapa Tapes North America LLC - February 07, 2020

Scapa Tapes North America LLC, a drug repackager/relabeler in Knoxville, TN, was cited for two observations during an FDA inspection. The firm failed to adequately document significant steps in batch production and control records and lacked written procedures for master production and control records. These issues indicate deficiencies in the firm's quality control and record-keeping practices.