FDA Inspection
Helio USA IncFDA Inspection 977018 - Helio USA Inc - July 06, 2016
Discuss this record with AI
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.
Record Details
This FDA Inspection record concerns Helio USA Inc, with an inspection on July 6, 2016, issued by the Center for Devices and Radiological Health, covering devices.
Open in Dashboard
ID · b074a18f-a2fc-4b27-a2a2-c3a09f159fb3
Violation Codes10
21 CFR 803.17(b)(1)21 CFR 820.100(a)21 CFR 820.100(b)21 CFR 820.15021 CFR 820.18621 CFR 820.198(a)21 CFR 820.198(b)21 CFR 820.20(c)21 CFR 820.2221 CFR 820.30(a)
Full citation text and observation details available on the Dashboard.