Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-01-27.
At a glance
Inspections
4
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Jan 2025 – 27 Jan 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 31 Jul 2019 – 1 Aug 2019 | Biologics | Clean | |
| 14 May 2019 – 20 May 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 4 Feb 2015 | Medical Devices & Rad Health | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Jan 2025
21 CFR 820.25(b)
Training - Lack of or inadequate procedures
Cited by Roy Baby, Elizabeth A Krolczyk, Katherine M Thames
27 Jan 2025
21 CFR 820.25(b)
Training - Lack of or inadequate procedures
Cited by Roy Baby, Elizabeth A Krolczyk, Katherine M Thames
27 Jan 2025
21 CFR 820.50(a)(3)
Acceptable supplier records, inadequate records
Cited by Roy Baby, Elizabeth A Krolczyk, Katherine M Thames
27 Jan 2025
21 CFR 820.50(a)(3)
Acceptable supplier records, inadequate records
Cited by Roy Baby, Elizabeth A Krolczyk, Katherine M Thames
Investigators
FDA investigators tied to this site in the record.
Roy Baby1 insp.
Elizabeth A Krolczyk1 insp.
Katherine M Thames1 insp.
Lauren M Lilly1 insp.
Jeremy L Stukes1 insp.
Akbar J Zaidi1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.50(a)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Acuity Surgical Devices, LLC's 2 Form 483s
Source PDFs, verbatim observations, 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