Overview
- 12 FDA inspections are on record.
- 12 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-02-23.
At a glance
Inspections
12
Form 483s
12
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Feb 2024 – 23 Feb 2024 | Human Drugs | 483 | View 483 → |
| 19 Jan 2023 – 31 Jan 2023 | Human Drugs | 483 | View 483 → |
| 15 Jan 2020 – 28 Jan 2020 | Human Drugs | 483 | View 483 → |
| 12 Mar 2018 – 6 Apr 2018 | Human Drugs | 483 | On file |
| 28 Nov 2017 – 6 Dec 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 12 Sep 2016 – 20 Sep 2016 | Human Drugs | 483 | On file |
| 3 Feb 2014 – 16 Feb 2014 | Human Drugs | 483 | On file |
| 7 Sep 2012 | Not recorded | 483 | View 483 → |
| 30 Jun 2011 | Not recorded | 483 | View 483 → |
| 30 Jul 2010 | Not recorded | 483 | On file |
| 11 Dec 2009 | Not recorded | 483 | View 483 → |
| 29 Jul 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
31 Jan 2023
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Sangeeta M Khurana, Rowena S Nguyen
6 Dec 2017
21 CFR 211.68(b)
Computer control of master formula records
Cited by Marcus F Yambot, Santiago Gallardo Johnson
Investigators
FDA investigators tied to this site in the record.
Erika V Butler3 insp.
Zachary L Stamm2 insp.
Theressa B Smith2 insp.
Patricia D Stahnke2 insp.
Courtney R Bratina1 insp.
Sangeeta M Khurana1 insp.
Rowena S Nguyen1 insp.
Jonathan R Campos1 insp.
Marcus F Yambot1 insp.
Santiago Gallardo Johnson1 insp.
Zachary A Bogorad1 insp.
Jamie L Dion1 insp.
Isabel Y Espinosa1 insp.
Kimberley A Hoefen1 insp.
Matthew R Dionne1 insp.
Caroline H Le1 insp.
Tamara L Setzer1 insp.
Linda F Murphy1 insp.
Ginger M Sykes1 insp.
Michael R Goga1 insp.
Elizabeth D Gonzales1 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 | 5x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.180(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iii) | 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 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(1)(i) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Tolmar Inc's 12 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