Form 483

Blue Runner Foods, Inc Form 483, 2014-03-13

FDA issued a Form 483 to Blue Runner Foods, Inc on 2014-03-13 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Blue Runner Foods, Inc · Gonzales, United States · Issued March 13, 2014

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.

13 Mar 2014
21 CFR 110.35(a)

Buildings/good repair

Cited by David J Leray, Wayne S Fortenberry, Natalie A Guidry

13 Mar 2014
21 CFR 110.80(b)(1)

Maintenance of equip., utensils, and finished food packaging

Cited by David J Leray, Wayne S Fortenberry, Natalie A Guidry

13 Mar 2014
21 CFR 113.40(a)(2)(iii)

Adjusted to agree with TID

Cited by David J Leray, Wayne S Fortenberry, Natalie A Guidry

13 Mar 2014
21 CFR 113.40(a)(13)

Measured, recorded

Cited by David J Leray, Wayne S Fortenberry, Natalie A Guidry

Inspected site

BRBlue Runner Foods, IncGonzales, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 113.40(a)(13)Cited across public-safe Form 483 observations1x
21 CFR 113.40(a)(2)(iii)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