Overview
- 13 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-04-24.
At a glance
Inspections
13
Form 483s
6
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Apr 2024 – 24 Apr 2024 | Human Drugs | 483 | On file |
| 16 Feb 2023 – 24 Feb 2023 | Human Drugs | 483 | On file |
| 23 May 2022 – 24 May 2022 | Human Drugs | Clean | |
| 12 Sep 2019 – 13 Sep 2019 | Human Drugs | Clean | |
| 13 Sep 2018 – 21 Sep 2018 | Human Drugs | Clean | |
| 2 Nov 2017 – 10 Nov 2017 | Biologics | 483 | On file |
| 18 Apr 2016 – 26 Apr 2016 | Human Drugs | 483 | View 483 → |
| 13 Feb 2014 – 20 Feb 2014 | Human Drugs | Clean | |
| 17 Jul 2012 | Not recorded | Clean | |
| 1 Apr 2010 | Not recorded | 483 | On file |
| 19 Sep 2008 | Not recorded | 483 | On file |
| 10 Sep 2003 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Apr 2016
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Sharon K Thoma, Liatte Krueger
26 Apr 2016
21 CFR 211.100(b)
Procedure Deviations Recorded and Justified
Cited by Sharon K Thoma, Liatte Krueger
26 Apr 2016
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Sharon K Thoma, Liatte Krueger
Investigators
FDA investigators tied to this site in the record.
Bo Chi1 insp.
Wendy G Tan1 insp.
Caryn M Mcnab1 insp.
Hamet M Toure1 insp.
MRA M BarbosaR1 insp.
MRA McCulloughJ1 insp.
Charles L Zhou1 insp.
Mihaly S Ligmond1 insp.
Sharon K Thoma1 insp.
Liatte Krueger1 insp.
Kimberley A Hoefen1 insp.
Russell K Riley1 insp.
Omotunde O Osunsanmi1 insp.
Thomas J Arista1 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 | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 6 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