FDA Inspection
Ziptek LLCZiptek LLC – FDA Inspection, May 22, 2024
Record Details
This FDA Inspection record concerns Ziptek LLC, with an inspection on May 22, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f6034f87-e55d-41f1-9755-929422b45ca2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1239943
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
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Other FDA inspections of Ziptek LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 8, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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