Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-03-28.
At a glance
Inspections
4
Form 483s
2
EIRs
2
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Mar 2019 – 28 Mar 2019 | Human Drugs | Clean | |
| 6 Mar 2017 – 8 Mar 2017 | Human Drugs | Clean | |
| 17 Oct 2016 – 21 Oct 2016 | Human Drugs | 483 | On file |
| 29 Jan 2014 – 31 Jan 2014 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
31 Jan 2014
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Michael A Charles, Edith M Gonzalez
31 Jan 2014
21 CFR 211.192
Written record of investigation incomplete
Cited by Michael A Charles, Edith M Gonzalez
Investigators
FDA investigators tied to this site in the record.
Zachary L Stamm1 insp.
Zachery L Miller1 insp.
Zachary A Bogorad1 insp.
Andrea S Heise1 insp.
Theressa B Smith1 insp.
Michael A Charles1 insp.
Edith M Gonzalez1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind TOLMAR Inc.'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