# FDA 483 - Scapa Tapes North America LLC - June 17, 2022

Source: https://www.keypedia.com/records/483/scapa-tapes-north-america-llc/fde713cc-dc9e-49f5-ab3b-7fa66a1b23d7

> FDA 483 for Scapa Tapes North America LLC on June 17, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Scapa Tapes North America LLC
- Inspection Date: 2022-06-17
- Product Type: device
- Office Name: New Orleans District Office
- Summary: 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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## Related Officers

- [Benjamin E. Bowen](https://www.keypedia.com/people/benjamin-e-bowen/7fdc5755-0d5d-45c9-93a0-3cb928156c1d)
- [Investigator ](https://www.keypedia.com/people/christina-l-bigham/f3da8e26-4a8c-43a8-8070-349fe4500289)

Company: https://www.keypedia.com/companies/scapa-tapes-north-america-llc/b3f257a0-3c5b-417a-b47b-17f9dbd625e2

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea