Overview
- 8 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-02-14.
At a glance
Inspections
8
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Feb 2025 – 14 Feb 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Jan 2025 – 16 Jan 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 22 Jan 2024 – 1 Feb 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 3 Nov 2022 – 8 Nov 2022 | Medical Devices & Rad Health | WL | View 483 → |
| 15 Aug 2022 – 19 Aug 2022 | Medical Devices & Rad Health | Clean | |
| 24 Jun 2019 – 28 Jun 2019 | Medical Devices & Rad Health | WL | View 483 → |
| 10 Dec 2018 – 13 Dec 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 12 Dec 2016 – 16 Dec 2016 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Feb 2025
21 CFR 820.20(c)
Management review - Lack of or inadequate procedures
Cited by Christine I Shaw
Investigators
FDA investigators tied to this site in the record.
Janet Pulver2 insp.
Christine I Shaw1 insp.
Kristin M Abaonza1 insp.
Alexandria L Capuano1 insp.
Terri E Gibson1 insp.
Juanj Wu1 insp.
Dustin P Tran1 insp.
Stuart W Russell1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.30(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 58.130(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 58.35(b)(3) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.120 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 58.10 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.130(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.190(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.29(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.29(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.35(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.35(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.43(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 50.27(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.120(a)(11) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.120(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.120(a)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.120(a)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.185(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.140(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.42 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Steiner Biotechnology LLC's 7 Form 483s
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