Form 483

Rising Sun Farms, Inc. Form 483, 2016-03-02

FDA issued a Form 483 to Rising Sun Farms, Inc. on 2016-03-02 with 6 public-safe observations.

483· Form 483 issuedFoods & Cosmetics6 observations

Rising Sun Farms, Inc. · Phoenix, United States · Issued March 2, 2016

Overview

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

2 Mar 2016
21 CFR 110.10(b)(5)

Glove condition

Cited by Sonia R Peterson, Shannon J Hall, Michael S Hudson

2 Mar 2016
21 CFR 110.20(b)(4)

Floors, walls and ceilings

Cited by Sonia R Peterson, Shannon J Hall, Michael S Hudson

2 Mar 2016
21 CFR 110.35(a)

Buildings/sanitary

Cited by Sonia R Peterson, Shannon J Hall, Michael S Hudson

2 Mar 2016
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Sonia R Peterson, Shannon J Hall, Michael S Hudson

2 Mar 2016
21 CFR 110.40(a)

Precluding contaminants

Cited by Sonia R Peterson, Shannon J Hall, Michael S Hudson

Inspected site

RSRising Sun Farms, Inc.Phoenix, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.40(a)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 6 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