FDA Inspection
LaunchPOrt LlcLaunchPOrt Llc – FDA Inspection, Jul 24, 2019
Record Details
This FDA Inspection record concerns LaunchPOrt Llc, with an inspection on July 24, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 0bfd739d-d663-4344-b9e5-fbe8d9ab7156
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1097310
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.75(a)Lack of or inadequate process validation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of LaunchPOrt Llc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 11, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for LaunchPOrt Llc
- FDA Inspection 1250892 - 2024-09-11
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