Form 483

Shin Shin Foods, Inc Form 483, 2015-04-08

FDA issued a Form 483 to Shin Shin Foods, Inc on 2015-04-08 with 10 public-safe observations.

483· Form 483 issuedFoods & Cosmetics10 observations

Shin Shin Foods, Inc · Portland, United States · Issued April 8, 2015

Overview

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

Inspectional observations

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

8 Apr 2015
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Mai Hang, David H Engelskirchen

8 Apr 2015
21 CFR 110.10(b)(7)

Storage of personal items

Cited by Mai Hang, David H Engelskirchen

8 Apr 2015
21 CFR 110.20(b)(1)

Sufficient space

Cited by Mai Hang, David H Engelskirchen

8 Apr 2015
21 CFR 110.20(b)(7)

Screening

Cited by Mai Hang, David H Engelskirchen

8 Apr 2015
21 CFR 110.35(a)

Buildings/sanitary

Cited by Mai Hang, David H Engelskirchen

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 observations1x
21 CFR 110.10(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.35(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)Cited across public-safe Form 483 observations1x
21 CFR 110.40(a)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(8)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 10 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