FDA Inspection
J-PAC LLCJ-PAC LLC – FDA Inspection, Nov 9, 2023
Record Details
This FDA Inspection record concerns J-PAC LLC, with an inspection on November 9, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 2d2190d0-6186-4c58-ad83-c21e5bb645fa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1222739
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 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 J-PAC LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 15, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 28, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 4, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for J-PAC LLC
- FDA Inspection 1035221 - 2017-12-15
- FDA Inspection 927996 - 2015-04-28
- FDA Inspection 785958 - 2012-06-04
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