Overview
- 15 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-03-07.
At a glance
Inspections
15
Form 483s
8
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Mar 2025 – 7 Mar 2025 | Human Drugs | 483 | View 483 → |
| 23 Jan 2020 – 30 Jan 2020 | Human Drugs | 483 | View 483 → |
| 11 Dec 2017 – 15 Dec 2017 | Human Drugs | 483 | View 483 → |
| 28 Mar 2016 – 1 Apr 2016 | Human Drugs | 483 | View 483 → |
| 19 Oct 2015 – 27 Oct 2015 | Human Drugs | 483 | View 483 → |
| 4 Mar 2015 – 18 Mar 2015 | Human Drugs | 483 | View 483 → |
| 3 Dec 2013 – 18 Dec 2013 | Human Drugs | 483 | View 483 → |
| 4 Dec 2012 | Not recorded | Clean | |
| 16 Mar 2011 | Not recorded | Clean | |
| 21 Jan 2011 | Not recorded | Clean | |
| 16 Jul 2010 | Not recorded | 483 | View 483 → |
| 14 Feb 2008 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
7 Mar 2025
21 CFR 211.122(d)
Label storage access limited to authorized personnel
Cited by Christopher R Czajka, Lena Nguyen
7 Mar 2025
21 CFR 211.25(a)
Training--operations, GMPs, written procedures
Cited by Christopher R Czajka, Lena Nguyen
Investigators
FDA investigators tied to this site in the record.
Uttaniti Limchumroon3 insp.
Christopher R Czajka1 insp.
Lena Nguyen1 insp.
Yumi J Hiramine1 insp.
Haroon Vohra1 insp.
Jai P Singh1 insp.
Walden H Lee1 insp.
Arie Menachem1 insp.
Lance A Finnical1 insp.
Joey V Quitania1 insp.
Stacie A Woods1 insp.
Saied A Asbagh1 insp.
Greg K Keshishyan1 insp.
Sonia R Peterson1 insp.
Sundy Ven1 insp.
Darrin E Davis1 insp.
Arsen Karapetyan1 insp.
Richmond K Yip1 insp.
S. L Brown1 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 | 6x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.137(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind PureTek Corporation's 8 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