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

Source: https://www.globalkeysolutions.net/records/483/scapa-tapes-north-america-llc/5e9174bc-2a5d-4153-b0c2-798fa396e173

> FDA 483 for Scapa Tapes North America LLC on January 23, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Scapa Tapes North America LLC
- Inspection Date: 2025-01-23
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: 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.

## Related Documents

- [483 - 2022-06-17](https://www.globalkeysolutions.net/records/483/scapa-tapes-north-america-llc/fde713cc-dc9e-49f5-ab3b-7fa66a1b23d7)

## Related Officers

- [Director of Compliance Branch](https://www.globalkeysolutions.net/people/ronda-r-lloyd-jones/1446ba41-f1f2-4d40-8902-021b2bef3a53)
- [Milton J. De Jesus Tavarez](https://www.globalkeysolutions.net/people/milton-j-de-jesus-tavarez/24d4ed81-7c7e-42d2-8888-1c56c25eec67)
- [Mickell Smith](https://www.globalkeysolutions.net/people/mickell-smith/ef92e41a-a16b-488a-a217-b10b54bb4f73)

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

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