Overview
- 6 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-03-10.
At a glance
Inspections
6
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Feb 2021 – 10 Mar 2021 | Foods & Cosmetics | 483 | View 483 → |
| 10 Feb 2020 – 13 Feb 2020 | Foods & Cosmetics | 483 | View 483 → |
| 28 May 2019 – 7 Jun 2019 | Foods & Cosmetics | 483 | View 483 → |
| 23 May 2018 – 1 Jun 2018 | Foods & Cosmetics | 483 | View 483 → |
| 6 Jul 2015 – 9 Jul 2015 | Foods & Cosmetics | 483 | View 483 → |
| 21 May 2015 – 22 May 2015 | Foods & Cosmetics | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Mar 2021
21 CFR 123.12(a)(2)
Importer verification
Cited by Eric J Reisenauer, Bernardica T Sculac-Stern
10 Mar 2021
21 CFR 123.6(b)
HACCP plan implementation
Cited by Eric J Reisenauer, Bernardica T Sculac-Stern
10 Mar 2021
21 CFR 123.6(c)(5)
Corrective action plan
Cited by Eric J Reisenauer, Bernardica T Sculac-Stern
Investigators
FDA investigators tied to this site in the record.
Peter M Trunk2 insp.
Jason Kwong2 insp.
Eric J Reisenauer1 insp.
Bernardica T Sculac-Stern1 insp.
Melissa N Gregorio1 insp.
Edwin A Evangelista1 insp.
Michael R Dominick1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 123.6(b) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 123.12(a)(2) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 123.6(c)(5) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 123.6(c)(3) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 123.11(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 123.6(c)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 123.6(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.4 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.10 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.7(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.7(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.8(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.8(a)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Uoya Inc. dba Shintoku, Inc. & Apollo Fish Co.'s 6 Form 483s
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