Form 483

Sunrise Noodle Corp. Form 483, 2015-09-25

FDA issued a Form 483 to Sunrise Noodle Corp. on 2015-09-25 with 8 public-safe observations.

483· Form 483 issuedFoods & Cosmetics8 observations

Sunrise Noodle Corp. · Chesapeake, United States · Issued September 25, 2015

Overview

  • 8 public-safe observations are available for this inspection.
  • 6 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.

25 Sep 2015
21 CFR 110.20(a)(1)

Harborage areas

Cited by Richard J Bashay

25 Sep 2015
21 CFR 110.20(b)(5)

Adequate lighting

Cited by Richard J Bashay

25 Sep 2015
21 CFR 110.20(b)(5)

Safety lighting and glass

Cited by Richard J Bashay

25 Sep 2015
21 CFR 110.20(b)(6)

Fans/air blowing equipment

Cited by Richard J Bashay

25 Sep 2015
21 CFR 110.20(b)(7)

Screening

Cited by Richard J Bashay

Inspected site

SNSunrise Noodle Corp.Chesapeake, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(b)(5)Cited across public-safe Form 483 observations2x
21 CFR 110.35(a)Cited across public-safe Form 483 observations2x
21 CFR 110.20(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 8 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