Company
United StatesScapa 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.
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)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 23, 2025 | VAI | Human Drugs · Drug Quality Assurance | 1259242 |
| June 17, 2022 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1173193 |
| February 7, 2020 | VAI | Human Drugs · Drug Quality Assurance | 1117120 |
| October 4, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1028558 |
| October 4, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1028544 |
| October 4, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1028522 |
| June 14, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 675434 |
FDA documents
EIRs (1)
People (4)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
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