Overview
- 4 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2025-11-12.
At a glance
Inspections
4
Form 483s
1
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Oct 2025 – 12 Nov 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Jan 2020 | Medical Devices & Rad Health | Clean | |
| 25 Jul 2017 – 27 Jul 2017 | Medical Devices & Rad Health | Clean | |
| 16 Mar 2015 – 20 Mar 2015 | Medical Devices & Rad Health | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Nov 2025
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Christina L Bigham
Investigators
FDA investigators tied to this site in the record.
Benjamin W Anderson2 insp.
Christina L Bigham1 insp.
Nicholas T Domer1 insp.
Ralph W Jerndal1 insp.
Rafael A Kaup1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Gyrus ACMI, Inc.'s 1 Form 483
Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat