Form 483

Marbran S.A. de C.V. (Plant 3) Form 483, 2016-05-13

FDA issued a Form 483 to Marbran S.A. de C.V. (Plant 3) on 2016-05-13 with 9 public-safe observations.

483· Form 483 issuedFoods & Cosmetics9 observations

Marbran S.A. de C.V. (Plant 3) · Jaral Del Progreso, Mexico · Issued May 13, 2016

Overview

  • 9 public-safe observations are available for this inspection.
  • 3 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.

13 May 2016
21 CFR 110.37(e)

Running water at suitable temperature

Cited by Edith M Gonzalez

13 May 2016
21 CFR 110.40(b)

Seams on food contact surfaces

Cited by Edith M Gonzalez

13 May 2016
21 CFR 110.80(b)(2)

Manufacturing conditions

Cited by Edith M Gonzalez

13 May 2016
21 CFR 110.80(b)(2)

Manufacturing conditions

Cited by Edith M Gonzalez

13 May 2016
21 CFR 110.37(e)

Running water at suitable temperature

Cited by Edith M Gonzalez

Inspected site

MSMarbran S.A. de C.V. (Plant 3)Jaral Del Progreso, Mexico

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.37(e)Cited across public-safe Form 483 observations3x
21 CFR 110.40(b)Cited across public-safe Form 483 observations3x
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations3x

Full 483 report

Get the verbatim text of all 9 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