Atlas

Form 483

Perla Del Sur Foods L.L.C. Form 483, 2019-07-03

FDA issued a Form 483 to Perla Del Sur Foods L.L.C. on 2019-07-03 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Perla Del Sur Foods L.L.C. · Ponce, United States · Issued July 3, 2019

Overview

  • 4 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.

3 Jul 2019
21 CFR 117.206(a)(1)

Modified Requirement Temp Control - Establish Implement

Cited by Miguel G Manzano

3 Jul 2019
21 CFR 117.35(a)

Sanitary Operations - Plant Maintenance

Cited by Miguel G Manzano

3 Jul 2019
21 CFR 117.35(a)

Sanitary Operations - Plant Sanitation

Cited by Miguel G Manzano

3 Jul 2019
21 CFR 117.10

Personnel

Cited by Miguel G Manzano

Inspected site

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

Inspection team

MGMiguel G Manzano

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.35(a)Cited across public-safe Form 483 observations2x
21 CFR 117.10Cited across public-safe Form 483 observations1x
21 CFR 117.206(a)(1)Cited across public-safe Form 483 observations1x

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