Form 483

Nicho Produce Co., Inc. Form 483, 2011-12-16

FDA issued a Form 483 to Nicho Produce Co., Inc. on 2011-12-16 with 8 public-safe observations.

483· Form 483 issued8 observations

Nicho Produce Co., Inc. · Edinburg, United States · Issued December 16, 2011

Overview

  • 8 public-safe observations are available for this inspection.
  • 8 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.

16 Dec 2011
21 CFR 110.20(a)(1)

Harborage areas

Cited by Anh Lac, Ed Gonzalez Vazquez, Roy Baby

16 Dec 2011
21 CFR 110.20(b)(4)

Drip and condensate

Cited by Anh Lac, Ed Gonzalez Vazquez, Roy Baby

16 Dec 2011
21 CFR 110.35(a)

Cleaning and sanitizing operations

Cited by Anh Lac, Ed Gonzalez Vazquez, Roy Baby

16 Dec 2011
21 CFR 110.37(b)(3)

As source of contamination

Cited by Anh Lac, Ed Gonzalez Vazquez, Roy Baby

16 Dec 2011
21 CFR 110.37(d)(4)

Doors opening into processing areas

Cited by Anh Lac, Ed Gonzalez Vazquez, Roy Baby

Inspected site

NPNicho Produce Co., Inc.Edinburg, United States

Inspection team

EGEd Gonzalez Vazquez

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)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.37(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.37(d)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.80Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(6)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 8 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