FDA Inspection
Gauthier Biomedical, Inc.FDA Inspection 998349 - Gauthier Biomedical, Inc. - December 15, 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 Gauthier Biomedical, Inc., with an inspection on December 15, 2016, issued by the Center for Devices and Radiological Health, covering devices.
Open in Dashboard
ID · 037ff17c-2f05-40b3-9555-0f288ff8f60d
Violation Codes5
21 CFR 803.18(b)(1)(i)21 CFR 803.18(e)21 CFR 820.100(a)21 CFR 820.198(a)21 CFR 820.50
Full citation text and observation details available on the Dashboard.