Form 483

Planta Herdez San Luis Industrias Form 483, 2016-08-31

FDA issued a Form 483 to Planta Herdez San Luis Industrias on 2016-08-31 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Planta Herdez San Luis Industrias · San Luis Potosi, Mexico · Issued August 31, 2016

Overview

  • 2 public-safe observations are available for this inspection.
  • 1 structured CFR citation is represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

31 Aug 2016
21 CFR 108.25(c)(2)

Process filing

Cited by Karla J Gibler, Natalie A Guidry

31 Aug 2016
21 CFR 108.25(c)(2)

Process filing

Cited by Karla J Gibler, Natalie A Guidry

Inspected site

PHPlanta Herdez San Luis IndustriasSan Luis Potosi, Mexico

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 108.25(c)(2)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 2 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