Overview
- 10 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-05-02.
At a glance
Inspections
10
Form 483s
2
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Apr 2024 – 2 May 2024 | Biologics | 483 | View 483 → |
| 9 Apr 2019 – 11 Apr 2019 | Biologics | Clean | |
| 30 Jan 2019 – 1 Feb 2019 | Human Drugs | Clean | |
| 23 Jan 2019 – 25 Jan 2019 | Human Drugs | Clean | |
| 15 Aug 2016 – 17 Aug 2016 | Biologics | Clean | |
| 27 Aug 2014 | Human Drugs | Clean | |
| 7 Apr 2014 – 10 Apr 2014 | Human Drugs | Clean | |
| 2 Aug 2011 | Not recorded | Clean | |
| 5 May 2011 | Not recorded | 483 | View 483 → |
| 29 Dec 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
2 May 2024
21 CFR 1271.195(a)
Adequate control, proper conditions
Cited by Leslie W Gilbert, Tammara A Stephens
2 May 2024
21 CFR 1271.195(a)(1)
Temperature and humidity controls
Cited by Leslie W Gilbert, Tammara A Stephens
2 May 2024
21 CFR 1271.195(a)(3)
Aseptic processing---cleaning, disinfecting
Cited by Leslie W Gilbert, Tammara A Stephens
2 May 2024
21 CFR 1271.195(c)
Monitoring-microorganisms where appropriate
Cited by Leslie W Gilbert, Tammara A Stephens
Investigators
FDA investigators tied to this site in the record.
Leslie W Gilbert2 insp.
Cordelia J Brammer2 insp.
Veronica Fuentes2 insp.
Jawaid Hamid2 insp.
Tammara A Stephens1 insp.
Kimberly C Delk-Brooks1 insp.
Trang N Cox1 insp.
Melanie M Walker1 insp.
Gabriel R Mclemore1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.195(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.195(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.195(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.195(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.200(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.210(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.250(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind North American Science Associates, LLC's 2 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