FDA Inspection
Johnson Medtech LLCJohnson Medtech LLC – FDA Inspection, Nov 27, 2023
Record Details
This FDA Inspection record concerns Johnson Medtech LLC, with an inspection on November 27, 2023, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 7c8a6ca5-b18c-4b67-bc39-607a9d2d8fb2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1223759
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.86Acceptance status
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.86Acceptance status
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Johnson Medtech LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 8, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 6, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Johnson Medtech LLC
- FDA Inspection 1192743 - 2022-12-08
- FDA Inspection 1093160 - 2019-06-06
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.