Form 483

Surata Soyfoods Inc Form 483, 2017-09-26

FDA issued a Form 483 to Surata Soyfoods Inc on 2017-09-26 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Surata Soyfoods Inc · Eugene, United States · Issued September 26, 2017

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

26 Sep 2017
21 CFR 110.35(a)

Buildings/good repair

Cited by Celia L Hutchinstein, Celia L Silverstein

26 Sep 2017
21 CFR 110.35(d)(5)

Shown to be effective

Cited by Celia L Hutchinstein, Celia L Silverstein

26 Sep 2017
21 CFR 110.80(b)(2)

Manufacturing conditions

Cited by Celia L Hutchinstein, Celia L Silverstein

Inspected site

SSSurata Soyfoods IncEugene, United States

Inspection team

CLCelia L Silverstein

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 observations

Every observation in full, 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