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Form 483

Sunshine Mills, Inc. Form 483, 2018-12-13

FDA issued a Form 483 to Sunshine Mills, Inc. on 2018-12-13 with 3 public-safe observations.

483· Form 483 issuedAnimal Drugs & Feeds3 observations

Sunshine Mills, Inc. · Tupelo, United States · Issued December 13, 2018

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.

13 Dec 2018
21 CFR 507.120(b)

Supply-Chain Written Procedures for Receiving Raw Materials

Cited by Sidney M Smith, Justin N Henson

13 Dec 2018
21 CFR 507.34(a)(1)

Preventive Controls

Cited by Sidney M Smith, Justin N Henson

13 Dec 2018
FDCA 417(d)(1)(A)

Reportable food report - submission

Cited by Sidney M Smith, Justin N Henson

Inspected site

SMSunshine Mills, Inc.Tupelo, United States

Inspection team

SMSidney M Smith
JNJustin N Henson

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 507.120(b)Cited across public-safe Form 483 observations1x
21 CFR 507.34(a)(1)Cited across public-safe Form 483 observations1x
FDCA 417(d)(1)(A)Cited across public-safe Form 483 observations1x

Source document

PDF
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Form 483 source document

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Full 483 report

Get the verbatim text of all 3 observations

The source PDF, 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