Atlas

Form 483

Uoya Inc. dba Shintoku, Inc. & Apollo Fish Co. Form 483, 2020-02-13

FDA issued a Form 483 to Uoya Inc. dba Shintoku, Inc. & Apollo Fish Co. on 2020-02-13 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Uoya Inc. dba Shintoku, Inc. & Apollo Fish Co. · Bronx, United States · Issued February 13, 2020

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 structured CFR citations are represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

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

13 Feb 2020
21 CFR 117.4

Training of employees and records

Cited by Peter M Trunk, Melissa N Gregorio, Edwin A Evangelista

13 Feb 2020
21 CFR 123.11(b)

Sanitation monitoring

Cited by Peter M Trunk, Melissa N Gregorio, Edwin A Evangelista

13 Feb 2020
21 CFR 123.12(a)(2)

Importer verification

Cited by Peter M Trunk, Melissa N Gregorio, Edwin A Evangelista

Inspected site

UIUoya Inc. dba Shintoku, Inc. & Apollo Fish Co.Bronx, United States

Inspection team

PMPeter M Trunk
MNMelissa N Gregorio
EAEdwin A Evangelista

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.4Cited across public-safe Form 483 observations1x
21 CFR 123.11(b)Cited across public-safe Form 483 observations1x
21 CFR 123.12(a)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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