Form 483

Perla Del Sur Foods L.L.C. Form 483, 2018-06-01

FDA issued a Form 483 to Perla Del Sur Foods L.L.C. on 2018-06-01 with 7 public-safe observations.

483· Form 483 issuedFoods & Cosmetics7 observations

Perla Del Sur Foods L.L.C. · Ponce, United States · Issued June 1, 2018

Overview

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

Inspectional observations

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

1 Jun 2018
21 CFR 110.20(a)(1)

Harborage areas

Cited by Miguel G Manzano, Aaron P Wozniak

1 Jun 2018
21 CFR 110.20(b)(7)

Screening

Cited by Miguel G Manzano, Aaron P Wozniak

1 Jun 2018
21 CFR 110.35(d)(5)

Shown to be effective

Cited by Miguel G Manzano, Aaron P Wozniak

1 Jun 2018
21 CFR 110.80(a)(1)

Storage

Cited by Miguel G Manzano, Aaron P Wozniak

1 Jun 2018
21 CFR 110.35(a)

Buildings/sanitary

Cited by Miguel G Manzano, Aaron P Wozniak

Inspected site

PDPerla Del Sur Foods L.L.C.Ponce, United States

Inspection team

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)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.80Cited across public-safe Form 483 observations1x
21 CFR 110.80(a)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 7 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