FDA Inspection
Scapa Tapes North America LLCScapa Tapes North America LLC – FDA Inspection, Jan 23, 2025
Record Details
This FDA Inspection record concerns Scapa Tapes North America LLC, with an inspection on January 23, 2025, issued by the New Orleans District Office, covering human drugs.
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ID · 98de9052-713b-4503-88a9-317b7f0fcc67
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1259242
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(a)Approval and review of procedures
- 21 CFR 211.110(a)Written in-process control procedures
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Other FDA inspections of Scapa Tapes North America LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| June 17, 2022 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 7, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 4, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 4, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 4, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Scapa Tapes North America LLC
- FDA Inspection 1173193 - 2022-06-17
- FDA Inspection 1117120 - 2020-02-07
- FDA Inspection 1028558 - 2017-10-04
- FDA Inspection 1028544 - 2017-10-04
- FDA Inspection 1028522 - 2017-10-04
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