Overview
- 12 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-07-24.
At a glance
Inspections
12
Form 483s
6
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Jul 2025 – 24 Jul 2025 | Human Drugs | 483 | View 483 → |
| 8 May 2025 – 15 May 2025 | Biologics | Clean | |
| 13 Jan 2020 – 15 Jan 2020 | Human Drugs | Clean | |
| 28 Nov 2016 – 2 Dec 2016 | Human Drugs | 483 | View 483 → |
| 3 Sep 2014 – 5 Sep 2014 | Human Drugs | Clean | |
| 14 Aug 2013 – 19 Aug 2013 | Human Drugs | 483 | View 483 → |
| 14 Oct 2011 | Not recorded | 483 | View 483 → |
| 22 Nov 2010 | Not recorded | Clean | |
| 24 Sep 2010 | Not recorded | 483 | View 483 → |
| 16 Jan 2008 | Not recorded | 483 | On file |
| 18 Aug 2003 | Not recorded | Clean | |
| 1 Feb 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Jul 2025
21 CFR 211.180(c)
Records not made readily available to FDA
Cited by Bryan A Galvez, Lillian S Wu, Rowena S Nguyen
24 Jul 2025
21 CFR 211.180(e)
Records reviewed annually
Cited by Bryan A Galvez, Lillian S Wu, Rowena S Nguyen
24 Jul 2025
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Bryan A Galvez, Lillian S Wu, Rowena S Nguyen
24 Jul 2025
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Bryan A Galvez, Lillian S Wu, Rowena S Nguyen
24 Jul 2025
21 CFR 211.42(c)(10)(vi)
Equipment to control conditions
Cited by Bryan A Galvez, Lillian S Wu, Rowena S Nguyen
Investigators
FDA investigators tied to this site in the record.
Gene D Arcy2 insp.
Bryan A Galvez1 insp.
Lillian S Wu1 insp.
Rowena S Nguyen1 insp.
Melsomar R Ramos1 insp.
Darren S Brown1 insp.
Liming Zhang1 insp.
Arsen Karapetyan1 insp.
Thao T Kwan1 insp.
Lilly O Barton1 insp.
Joey V Quitania1 insp.
Kham Phommachanh1 insp.
Esther B Gamallo Herrera1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 1271.190(a) | Cited across public-safe Form 483 observations | 1x |
| 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 211.180(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | 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)(vi) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind North American Science Associates, LLC'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