FDA Inspection
Ziptek LLCZiptek LLC – FDA Inspection, May 8, 2018
Record Details
This FDA Inspection record concerns Ziptek LLC, with an inspection on May 8, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d14a63ed-9f35-425c-a7df-97eb603686bf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1051750
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.75(b)(2)Documentation of validated process performance
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Other FDA inspections of Ziptek LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 22, 2024 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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