Form 483

Rising Sun Farms, Inc. Form 483, 2018-03-12

FDA issued a Form 483 to Rising Sun Farms, Inc. on 2018-03-12 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Rising Sun Farms, Inc. · Phoenix, United States · Issued March 12, 2018

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

12 Mar 2018
21 CFR 117.35(a)

Sanitary Operations - Plant Maintenance

Cited by Sonia R Peterson, Beau R Lamb, Michael S Hudson

12 Mar 2018
21 CFR 117.35(b)(1)

Cleaning and sanitizing substances- safe and adequate

Cited by Sonia R Peterson, Beau R Lamb, Michael S Hudson

12 Mar 2018
21 CFR 117.80(a)

Plant Operations - precautions

Cited by Sonia R Peterson, Beau R Lamb, Michael S Hudson

12 Mar 2018
21 CFR 117.80(c)

Manufacturing, Processing, Packing, Holding - Controls

Cited by Sonia R Peterson, Beau R Lamb, 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 117.35(a)Cited across public-safe Form 483 observations1x
21 CFR 117.35(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.80(a)Cited across public-safe Form 483 observations1x
21 CFR 117.80(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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