FDA Inspection
Sacred Heart Healthcare SystemSacred Heart Healthcare System – FDA Inspection, May 18, 2016
Record Details
This FDA Inspection record concerns Sacred Heart Healthcare System, with an inspection on May 18, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 18, 2016
- Product Type
- Devices
View Company Profile
ID · 9ce6603c-911c-4107-a755-9ee819708f34
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 970797
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.108(c)Members present for review
- 21 CFR 56.108(a)(2)More frequent reviews, verification of no changes
- 21 CFR 56.108(a)(3)Prompt reporting of changes
- 21 CFR 56.108(b)(2)Prompt reporting of noncompliance
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.