Atlas

Form 483

Otsubo Seafood Co., Ltd Form 483, 2026-06-02

FDA issued a Form 483 to Otsubo Seafood Co., Ltd on 2026-06-02 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Otsubo Seafood Co., Ltd · Yaizu, Japan · Issued June 2, 2026

Overview

  • 4 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

2 Jun 2026
21 CFR 123.6(c)(2)

Critical control points

Cited by Richard G Fochesato

2 Jun 2026
21 CFR 123.6(c)(2)

Critical control points

Cited by Richard G Fochesato

2 Jun 2026
21 CFR 123.6(c)(3)

Critical limits

Cited by Richard G Fochesato

2 Jun 2026
21 CFR 123.6(c)(3)

Critical limits

Cited by Richard G Fochesato

Inspected site

OSOtsubo Seafood Co., LtdYaizu, Japan

Inspection team

RGRichard G Fochesato

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.6(c)(2)Cited across public-safe Form 483 observations2x
21 CFR 123.6(c)(3)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 4 observations

The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere