FDA 483 - Scapa Tapes North America LLC - January 23, 2025

Scapa Tapes North America LLC in Knoxville, TN, was inspected and cited for significant deficiencies in its quality control unit, laboratory operations, and adherence to written procedures. Observations included releasing untested batches, inadequate laboratory record-keeping, and using undocumented procedures for batch release. These issues indicate a systemic failure to follow established quality and testing protocols.