Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-08.
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 |
|---|---|---|---|
| 27 Apr 2026 – 8 May 2026 | Human Drugs | 483 | On file |
| 29 May 2023 – 9 Jun 2023 | Human Drugs | 483 | View 483 → |
| 24 Jun 2019 – 28 Jun 2019 | Human Drugs | 483 | On file |
| 25 Feb 2019 – 1 Mar 2019 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Jun 2023
21 CFR 211.188(b)(12)
Investigations made into any unexplained discrepancy
Cited by Matthew B Casale
Investigators
FDA investigators tied to this site in the record.
Marcellinus D Dordunoo2 insp.
Eileen A Liu1 insp.
Matthew B Casale1 insp.
Christopher T Middendorf1 insp.
Yifan Wang1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(12) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 4 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