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Scapa Tapes North America LLC, Knoxville, TN – FDA Inspections

Inspection records and compliance data for Scapa Tapes North America LLC in Knoxville, Tennessee. 7 FDA inspections on record, 1 Form 483, last inspected January 23, 2025.

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Company Profile

This profile covers Scapa Tapes North America LLC based in Knoxville, Tennessee, United States.

FDA Inspection History

FDA inspections
7
OAI
0
VAI
3
NAI
4
Form 483s
1
Warning letters
0

First inspected June 14, 2010. Last inspected January 23, 2025.

Most cited issue areas

  • Approval and review of procedures1 inspection
  • Batch production and Batch Control Record Requirements1 inspection
  • DMR - not or inadequately maintained1 inspection

FDA inspections (7)

DateResultFDA center(s)Insp. #
January 23, 2025VAIHuman Drugs · Drug Quality Assurance1259242
June 17, 2022VAIMedical Devices & Rad Health · Postmarket Assurance: Devices1173193
February 7, 2020VAIHuman Drugs · Drug Quality Assurance1117120
October 4, 2017NAIMedical Devices & Rad Health · Compliance: Devices1028558
October 4, 2017NAIMedical Devices & Rad Health · Compliance: Devices1028544
October 4, 2017NAIMedical Devices & Rad Health · Compliance: Devices1028522
June 14, 2010NAIMedical Devices & Rad Health · Compliance: Devices675434
FDA documents

Form 483s (2)

  • Form 483s · January 23, 2025
  • Form 483s · June 17, 2022

EIRs (1)

  • EIRs · June 17, 2022
People (4)
Christina L. Bigham
Person
Benjamin E. Bowen
Person
Ronda R. Lloyd-Jones
Person
Milton J. De Jesus Tavarez
Person
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Company Information

Name

Scapa Tapes North America LLC

FEI Number

3015200795

Address

2565 Bertelkamp Ln, Knoxville, Tennessee 37931, United States

Country

United States

ID: b3f257a0-3c5b-417a-b47b-17f9dbd625e2

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