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Form 483

Productos Pacheco, Inc. Form 483, 2015-07-08

FDA issued a Form 483 to Productos Pacheco, Inc. on 2015-07-08 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Productos Pacheco, Inc. · Bayamon, United States · Issued July 8, 2015

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.

8 Jul 2015
21 CFR 110.20(b)(5)

Safety lighting and glass

Cited by Pablo Feliciano

8 Jul 2015
21 CFR 110.37(d)(3)

Self-closing doors

Cited by Pablo Feliciano

8 Jul 2015
21 CFR 110.20(b)(5)

Safety lighting and glass

Cited by Pablo Feliciano

8 Jul 2015
21 CFR 110.37(d)(3)

Self-closing doors

Cited by Pablo Feliciano

Inspected site

PPProductos Pacheco, Inc.Bayamon, United States

Inspection team

PFPablo Feliciano

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(b)(5)Cited across public-safe Form 483 observations2x
21 CFR 110.37(d)(3)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