FDA Inspection
Johnson Medtech LLCJohnson Medtech LLC – FDA Inspection, Jun 6, 2019
Record Details
This FDA Inspection record concerns Johnson Medtech LLC, with an inspection on June 6, 2019, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 07497275-0bc8-4369-8844-9fafe409cf95
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1093160
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 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 |
|---|---|---|---|
| November 27, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 8, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Johnson Medtech LLC
- FDA Inspection 1223759 - 2023-11-27
- FDA Inspection 1192743 - 2022-12-08
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.