483
Scapa Tapes North America LLCFDA 483 - Scapa Tapes North America LLC - June 17, 2022
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Record Details
An FDA inspection of Scapa Tapes North America LLC in Knoxville, TN, identified a significant quality system deficiency. The firm failed to adequately maintain its device master record, specifically regarding specifications and instructions for in-process testing. This indicates a moderate severity issue related to device manufacturing control.
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ID · fde713cc-dc9e-49f5-ab3b-7fa66a1b23d7