Overview
- 7 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-01-31.
At a glance
Inspections
7
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Jan 2023 – 31 Jan 2023 | Human Drugs | Clean | |
| 13 Jun 2022 – 17 Jun 2022 | Human Drugs | 483 | View 483 → |
| 18 Feb 2020 – 24 Feb 2020 | Human Drugs | 483 | View 483 → |
| 23 May 2018 – 30 May 2018 | Human Drugs | Clean | |
| 6 Nov 2017 – 8 Nov 2017 | Human Drugs | Clean | |
| 18 Jul 2017 – 26 Jul 2017 | Human Drugs | 483 | View 483 → |
| 11 Apr 2016 – 15 Apr 2016 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Jun 2022
21 CFR 211.63
Equipment Design, Size and Location
Cited by Christopher M Jenner, Amir Alavi, Michael T Cyrus
17 Jun 2022
21 CFR 211.67(b)
Written procedures fail to include
Cited by Christopher M Jenner, Amir Alavi, Michael T Cyrus
17 Jun 2022
21 CFR 211.84(b)
Representative Samples
Cited by Christopher M Jenner, Amir Alavi, Michael T Cyrus
24 Feb 2020
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Michael A Charles, Zachary L Stamm
Investigators
FDA investigators tied to this site in the record.
Zachary L Stamm3 insp.
Jamie L Dion2 insp.
Zachery L Miller2 insp.
Sangeeta M Khurana1 insp.
Rowena S Nguyen1 insp.
Christopher M Jenner1 insp.
Amir Alavi1 insp.
Michael T Cyrus1 insp.
Michael A Charles1 insp.
Gerard T Schneider1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Tolmar, Inc.'s 4 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