Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-10-26.
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 |
|---|---|---|---|
| 19 Oct 2021 – 26 Oct 2021 | Human Drugs | 483 | View 483 → |
| 10 Feb 2020 – 20 Feb 2020 | Human Drugs | 483 | On file |
| 2 Oct 2017 – 18 Dec 2017 | Human Drugs | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Oct 2021
FDCA 501(a)(2)(A)
Hazardous drugs, prevention of cross-contamination
Cited by Truong X Nguyen, Scott N Lim
18 Dec 2017
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Liming Zhang, Alan P Kurtzberg
18 Dec 2017
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Liming Zhang, Alan P Kurtzberg
18 Dec 2017
21 CFR 211.166(a)
Results not used for expiration dates, storage cond.
Cited by Liming Zhang, Alan P Kurtzberg
Investigators
FDA investigators tied to this site in the record.
Truong X Nguyen1 insp.
Scott N Lim1 insp.
Rumany C Penn1 insp.
Michael T Cyrus1 insp.
Sammie P La1 insp.
Liming Zhang1 insp.
Alan P Kurtzberg1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| FDCA 501(a)(2)(A) | 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