Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-09-20.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Sep 2024 – 20 Sep 2024 | Human Drugs | WL | View 483 → |
| 25 Apr 2018 – 27 Apr 2018 | Human Drugs | Clean | |
| 21 Jan 2016 – 22 Jan 2016 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Sep 2024
21 CFR 211.160(a)
Lab controls established, including changes
Cited by Kejun Cheng, Shelby N Turner
20 Sep 2024
21 CFR 211.180(c)
Records not made readily available to FDA
Cited by Kejun Cheng, Shelby N Turner
20 Sep 2024
21 CFR 211.194(a)
Complete test data included in records
Cited by Kejun Cheng, Shelby N Turner
20 Sep 2024
21 CFR 211.194(d)
Laboratory equipment calibration records
Cited by Kejun Cheng, Shelby N Turner
Investigators
FDA investigators tied to this site in the record.
Kejun Cheng1 insp.
Shelby N Turner1 insp.
Laurimer Kuilan-Torres1 insp.
Lindsey M Schwierjohann1 insp.
Gang Wang1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 2 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