FDA Inspection
Gyrus ACMI, Inc.FDA Inspection 1295532 - Gyrus ACMI, Inc. - November 12, 2025
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 Gyrus ACMI, Inc., with an inspection on November 12, 2025, issued by the Minneapolis District Office, covering medical devices & rad health.
Open in Dashboard
ID · da9c0a28-2e60-4e7a-97cb-0e232a4b404a
Violation Codes8
21 CFR 820.100(a)21 CFR 820.18421 CFR 820.198(a)21 CFR 820.5021 CFR 820.75(a)21 CFR 820.75(b)21 CFR 820.80(b)21 CFR 820.90(a)
Full citation text and observation details available on the Dashboard.