Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-11.
At a glance
Inspections
4
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Nov 2025 – 11 Nov 2025 | Human Drugs | 483 | View 483 → |
| 19 Aug 2024 – 26 Aug 2024 | Human Drugs | 483 | On file |
| 23 Mar 2015 – 27 Mar 2015 | Human Drugs | 483 | On file |
| 26 Jul 2012 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Nov 2025
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Patty P Kaewussdangkul, WenNing Chan
11 Nov 2025
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Patty P Kaewussdangkul, WenNing Chan
11 Nov 2025
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Patty P Kaewussdangkul, WenNing Chan
Investigators
FDA investigators tied to this site in the record.
Patty P Kaewussdangkul1 insp.
WenNing Chan1 insp.
Gam S Zamil1 insp.
Cynthia Jim1 insp.
Peter E Baker1 insp.
Chiang Syin1 insp.
Candace S Tucker1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 3 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