Atlas

Form 483

Productos La Finca, Inc. Form 483, 2019-03-01

FDA issued a Form 483 to Productos La Finca, Inc. on 2019-03-01 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Productos La Finca, Inc. · Sabana Grande, United States · Issued March 1, 2019

Overview

  • 4 public-safe observations are available for this inspection.
  • 2 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.

1 Mar 2019
21 CFR 117.10

Personnel

Cited by Moraima J Ramos-Valle

1 Mar 2019
21 CFR 117.10

Personnel

Cited by Moraima J Ramos-Valle

1 Mar 2019
21 CFR 117.20(b)

Plant Construction and Design

Cited by Moraima J Ramos-Valle

1 Mar 2019
21 CFR 117.20(b)

Plant Construction and Design

Cited by Moraima J Ramos-Valle

Inspected site

PLProductos La Finca, Inc.Sabana Grande, United States

Inspection team

MJMoraima J Ramos-Valle

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.10Cited across public-safe Form 483 observations2x
21 CFR 117.20(b)Cited across public-safe Form 483 observations2x

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