Form 483

Sunshine Bottling Co, Inc. Form 483, 2010-06-17

FDA issued a Form 483 to Sunshine Bottling Co, Inc. on 2010-06-17 with 7 public-safe observations.

483· Form 483 issued7 observations

Sunshine Bottling Co, Inc. · Doral, United States · Issued June 17, 2010

Overview

  • 7 public-safe observations are available for this inspection.
  • 7 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.

17 Jun 2010
21 CFR 110.20(a)(1)

Harborage areas

Cited by Clara E Santiago

17 Jun 2010
21 CFR 110.20(b)(7)

Screening

Cited by Clara E Santiago

17 Jun 2010
21 CFR 120.6(a)

Sanitation SSOP - none or not implemented

Cited by Clara E Santiago

17 Jun 2010
21 CFR 120.6(b)

Sanitation monitoring

Cited by Clara E Santiago

17 Jun 2010
21 CFR 120.6(c)

SSOP records

Cited by Clara E Santiago

Inspected site

SBSunshine Bottling Co, Inc.Doral, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 120.6(a)Cited across public-safe Form 483 observations1x
21 CFR 120.6(b)Cited across public-safe Form 483 observations1x
21 CFR 120.6(c)Cited across public-safe Form 483 observations1x
21 CFR 120.7(a)Cited across public-safe Form 483 observations1x
21 CFR 120.8(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 7 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