Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-04-25.
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 |
|---|---|---|---|
| 14 Apr 2025 – 25 Apr 2025 | Human Drugs | 483 | View 483 → |
| 14 Jun 2021 – 18 Jun 2021 | Human Drugs | Clean | |
| 23 Jul 2018 – 3 Aug 2018 | Human Drugs | 483 | View 483 → |
| 22 Dec 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Lakecha N Lewis1 insp.
Saaman Habibi1 insp.
Sherri N Rohlf1 insp.
Christina D Mello1 insp.
Diane C Van Leeuwen1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 312.60 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 312.66 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Stephen G. Thein, Ph.D.'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