FDA Inspection
Sentiar IncSentiar Inc – FDA Inspection, Mar 21, 2024
Record Details
This FDA Inspection record concerns Sentiar Inc, with an inspection on March 21, 2024, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · dc6646d1-70b3-4176-ad8c-c51c43b5b0f6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1233626
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.198(a)Complaints
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 830.310(b)GUDID Information required for unique device identification.
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.