FDA EIR - Scapa Tapes North America LLC - June 17, 2022

An FDA inspection of Scapa Tapes North America LLC in Knoxville, TN, took place from June 15-17, 2022, as a preannounced Quality System Inspection Technique (QSIT) Level I Abbreviated review of their medical device manufacturing operations. Conducted under Compliance Program 7382.845, the inspection primarily focused on the Corrective and Preventative Action (CAPA) and Production and Process Controls subsystems, particularly for Breathe Right Nasal Strips. The main violation cited on FDA Form 483 was the inadequate maintenance of a device master record (DMR), specifically, the absence of adhesion testing specifications and referenced procedures for the Breathe Right Nasal Strip, a direct violation of 21 CFR 820.181. Additional concerns discussed included the lack of documented justification for averaging adhesion test data, an ineffective CAPA system failing to correct identified issues (as documented in CAPA 2022-008), and procedures not reflecting current practices. Management was informed that these conditions could be considered violations of the FD&C Act, potentially leading to legal sanctions. The company responded by submitting draft Process Instructions to update the DMR for the cited deficiency, which resulted in the observation being noted as "Reported corrected, not verified." Scapa Tapes North America LLC verbally committed to addressing all identified issues.