Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-11.
At a glance
Inspections
4
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Jun 2026 – 11 Jun 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 28 Feb 2023 – 3 Mar 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 10 Feb 2017 – 23 Feb 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Mar 2014 – 31 Mar 2014 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Jun 2026
ISO 13485:2016 Clause 4.1.2
Risk-based approach not applied to QMS processes
Cited by Laureen M Geniusz
11 Jun 2026
ISO 13485:2016 Clause 4.2.4
Document Control Procedure Inadequate
Cited by Laureen M Geniusz
11 Jun 2026
ISO 13485:2016 Clause 7.3.5
Records of design and development reviews not maintained
Cited by Laureen M Geniusz
Investigators
FDA investigators tied to this site in the record.
Laureen M Geniusz3 insp.
Talmane J Fisher1 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 | 3x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.20(b)(3)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 4.1.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 4.2.4 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.3.5 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Surgical Theater Inc's 4 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