Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-09-17.
At a glance
Inspections
3
Form 483s
3
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Sep 2025 – 17 Sep 2025 | Human Drugs | 483 | View 483 → |
| 6 Mar 2019 – 7 Mar 2019 | Human Drugs | 483 | View 483 → |
| 19 Feb 2014 – 21 Feb 2014 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Sep 2025
21 CFR 314.81(b)(1)(ii)
Contamination, chemical or physical change, deterioration
Cited by Andrew Le
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 212.20(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 212.20(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 212.40(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.71(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 3 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