Scapa Tapes North America LLC FDA Record
Scapa Tapes North America LLC has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Scapa Tapes North America LLC" is on file.
- Latest inspection
- Jan 23, 2025 · VAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 8 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 1 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 1 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 3 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jan 23, 2025 | Knoxville, TN | Drugs | Voluntary Action Indicated (VAI) | 3015200795 |
| Jun 17, 2022 | Knoxville, TN | Devices | Voluntary Action Indicated (VAI) | 3015200795 |
| Feb 7, 2020 | Knoxville, TN | Drugs | Voluntary Action Indicated (VAI) | 3015200795 |
| Oct 4, 2017 | Knoxville, TN | Devices | No Action Indicated (NAI) | 3015200795 |
| Oct 4, 2017 | Knoxville, TN | Devices | No Action Indicated (NAI) | 3015200795 |
| Oct 4, 2017 | Knoxville, TN | Devices | No Action Indicated (NAI) | 3015200795 |
| Nov 3, 2010 | Windsor, CT | Drugs | No Action Indicated (NAI) | 3001830567 |
| Jun 14, 2010 | Knoxville, TN | Devices | No Action Indicated (NAI) | 3015200795 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3015200795 | Knoxville, TN | 7 | Jan 23, 2025 |
| FEI 3001830567 | Windsor, CT | 1 | Nov 3, 2010 |
Scapa Tapes North America LLC and the FDA: common questions
Has Scapa Tapes North America LLC received an FDA warning letter?
No FDA warning letter addressed to the name "Scapa Tapes North America LLC" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Scapa Tapes North America LLC received an FDA Form 483?
FDA has not published a Form 483 for "Scapa Tapes North America LLC" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Scapa Tapes North America LLC?
The most recent FDA inspection on file ended Jan 23, 2025 at Knoxville, TN and was classified VAI. FDA has 8 inspections of Scapa Tapes North America LLC on file.
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