Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-08-14.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Aug 2019 – 14 Aug 2019 | Human Drugs | 483 | View 483 → |
| 9 Jul 2018 – 9 Aug 2018 | Human Drugs | 483 | On file |
| 28 Nov 2016 – 2 Dec 2016 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Aug 2019
21 CFR 212.20(d)
Determination need for investigation
Cited by Uttaniti Limchumroon, Walden H Lee
14 Aug 2019
21 CFR 212.20(e)
Written QA procedures established, followed
Cited by Uttaniti Limchumroon, Walden H Lee
Investigators
FDA investigators tied to this site in the record.
Walden H Lee2 insp.
Uttaniti Limchumroon1 insp.
Joey V Quitania1 insp.
Amanda L Fyles1 insp.
Linda F Murphy1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 212.60(g)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 212.20(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.20(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.30(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.50(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.60(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.60(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.60(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.70(b) | 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