Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2025-03-21.
At a glance
Inspections
1
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Mar 2025 – 21 Mar 2025 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Mar 2025
21 CFR 58.113(a)(1)
Mixtures: uniformity and concentration
Cited by Hugh M Mcclure, Zhou Chen, Mark J Seaton
21 Mar 2025
21 CFR 58.185(c)
Final report: corrections or additions
Cited by Hugh M Mcclure, Zhou Chen, Mark J Seaton
21 Mar 2025
21 CFR 58.190(a)
Archives: data, documentation, specimens
Cited by Hugh M Mcclure, Zhou Chen, Mark J Seaton
21 Mar 2025
21 CFR 58.35(b)(6)
QAU: review final study report
Cited by Hugh M Mcclure, Zhou Chen, Mark J Seaton
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 58.113(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.185(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.190(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.35(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.81(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.90(g) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 1 Form 483
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