Form 483

Refresco Beverages US Inc. Form 483, 2012-10-10

FDA issued a Form 483 to Refresco Beverages US Inc. on 2012-10-10 with 6 public-safe observations.

483· Form 483 issued6 observations

Refresco Beverages US Inc. · Lakeland, United States · Issued October 10, 2012

Overview

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

10 Oct 2012
21 CFR 110.10(b)(9)

Precautions against contamination--micro, foreign substances

Cited by Meredith M Cobb, Ashley Segura

10 Oct 2012
21 CFR 110.20(b)(7)

Screening

Cited by Meredith M Cobb, Ashley Segura

10 Oct 2012
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Meredith M Cobb, Ashley Segura

10 Oct 2012
21 CFR 110.37(d)(2)

Good repair

Cited by Meredith M Cobb, Ashley Segura

10 Oct 2012
21 CFR 110.80(a)(1)

Storage

Cited by Meredith M Cobb, Ashley Segura

Inspected site

RBRefresco Beverages US Inc.Lakeland, United States

Inspection team

MMMeredith M Cobb

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(9)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
21 CFR 110.37(d)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.80(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 120.12(b)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