FDA Inspection
Empyrean Medical Systems IncEmpyrean Medical Systems Inc – FDA Inspection, Jun 5, 2024
Record Details
This FDA Inspection record concerns Empyrean Medical Systems Inc, with an inspection on June 5, 2024, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · eaab6583-1d5a-46f6-b276-adcb745221fa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1240157
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
15- 21 CFR 1002.30(a)(1)Quality control procedures
- 21 CFR 1002.30(a)(4)Communication with dealers et. al.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.30(c)Design input - documentation
Showing 10 of 15 citations.
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.