Form 483

Shin Shin Foods, Inc Form 483, 2016-01-25

FDA issued a Form 483 to Shin Shin Foods, Inc on 2016-01-25 with 30 public-safe observations.

483· Form 483 issuedFoods & Cosmetics30 observations

Shin Shin Foods, Inc · Portland, United States · Issued January 25, 2016

Overview

  • 30 public-safe observations are available for this inspection.
  • 15 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.

25 Jan 2016
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Beau R Lamb, Mai Hang, Philippe A Cornet

25 Jan 2016
21 CFR 110.10(b)(4)

Unsecured jewelry

Cited by Beau R Lamb, Mai Hang, Philippe A Cornet

25 Jan 2016
21 CFR 110.10(b)(6)

Failure to wear

Cited by Beau R Lamb, Mai Hang, Philippe A Cornet

25 Jan 2016
21 CFR 110.10(b)(7)

Storage of personal items

Cited by Beau R Lamb, Mai Hang, Philippe A Cornet

25 Jan 2016
21 CFR 110.20(b)(7)

Screening

Cited by Beau R Lamb, Mai Hang, Philippe A Cornet

Inspected site

SSShin Shin Foods, IncPortland, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(3)Cited across public-safe Form 483 observations2x
21 CFR 110.10(b)(4)Cited across public-safe Form 483 observations2x
21 CFR 110.10(b)(6)Cited across public-safe Form 483 observations2x
21 CFR 110.10(b)(7)Cited across public-safe Form 483 observations2x
21 CFR 110.20(b)(7)Cited across public-safe Form 483 observations2x
21 CFR 110.35(a)Cited across public-safe Form 483 observations2x
21 CFR 110.35(b)(2)Cited across public-safe Form 483 observations2x
21 CFR 110.35(c)Cited across public-safe Form 483 observations2x
21 CFR 110.35(d)Cited across public-safe Form 483 observations2x
21 CFR 110.35(d)(3)Cited across public-safe Form 483 observations2x
21 CFR 110.35(d)(5)Cited across public-safe Form 483 observations2x
21 CFR 110.37(b)(3)Cited across public-safe Form 483 observations2x
21 CFR 110.40(a)Cited across public-safe Form 483 observations2x
21 CFR 110.80(a)(7)Cited across public-safe Form 483 observations2x
21 CFR 110.80(b)(8)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 30 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