FDA Inspection
Primotec LLCPrimotec LLC – FDA Inspection, Sep 25, 2019
Record Details
This FDA Inspection record concerns Primotec LLC, with an inspection on September 25, 2019, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · de0c1633-3d18-4d1d-909f-e9acae97e6d3
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1102929
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(a)Complaints
- 21 CFR 820.40Procedures not adequately established or maintained
Full citation text and observation details available on the Dashboard.
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.