Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-02-25.
At a glance
Inspections
4
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Feb 2023 – 25 Feb 2023 | Human Drugs | 483 | On file |
| 15 Feb 2021 – 25 Feb 2021 | Human Drugs | WL | View 483 → |
| 22 Jul 2019 – 30 Jul 2019 | Human Drugs | 483 | On file |
| 15 Jan 2018 – 23 Jan 2018 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Feb 2021
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Roger F Zabinski, Arsen Karapetyan
25 Feb 2021
21 CFR 211.188(b)(4)
Weights and measures of components used
Cited by Roger F Zabinski, Arsen Karapetyan
25 Feb 2021
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Roger F Zabinski, Arsen Karapetyan
25 Feb 2021
21 CFR 211.192
Written record of investigation incomplete
Cited by Roger F Zabinski, Arsen Karapetyan
25 Feb 2021
21 CFR 211.194(a)
Complete test data included in records
Cited by Roger F Zabinski, Arsen Karapetyan
Investigators
FDA investigators tied to this site in the record.
Michele Perry-Williams1 insp.
Michael E Maselli1 insp.
Roger F Zabinski1 insp.
Arsen Karapetyan1 insp.
Sarah E Rhoades1 insp.
Steven Fong1 insp.
Marion Michaelis1 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 | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(b) | 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 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind TOYOBO CO., LTD.'s 4 Form 483s
Source PDFs 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