Form 483

Sun Sen Co., Inc. Form 483, 2018-07-26

FDA issued a Form 483 to Sun Sen Co., Inc. on 2018-07-26 with 16 public-safe observations.

483· Form 483 issuedFoods & Cosmetics16 observations

Sun Sen Co., Inc. · Sacramento, United States · Issued July 26, 2018

Overview

  • 16 public-safe observations are available for this inspection.
  • 8 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.

26 Jul 2018
21 CFR 112.11

General requirement to prevent foreseeable food safety hazards

Cited by Ismael Garibay

26 Jul 2018
21 CFR 112.11

General requirement to prevent foreseeable food safety hazards

Cited by Ismael Garibay

26 Jul 2018
21 CFR 112.123(a)

Equip & tools - cleanability

Cited by Ismael Garibay

26 Jul 2018
21 CFR 112.123(a)

Equip & tools - cleanability

Cited by Ismael Garibay

26 Jul 2018
21 CFR 112.123(d)(2)

Non-food-contact surface maintenance and cleaning

Cited by Ismael Garibay

Inspected site

SSSun Sen Co., Inc.Sacramento, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 112.11Cited across public-safe Form 483 observations2x
21 CFR 112.123(a)Cited across public-safe Form 483 observations2x
21 CFR 112.123(d)(2)Cited across public-safe Form 483 observations2x
21 CFR 112.142(e)(1)Cited across public-safe Form 483 observations2x
21 CFR 112.144(a)Cited across public-safe Form 483 observations2x
21 CFR 112.147(a)Cited across public-safe Form 483 observations2x
21 CFR 112.22(a)Cited across public-safe Form 483 observations2x
21 CFR 112.22(c)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 16 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