Form 483

Valentini Italian Specialties, Co. Form 483, 2017-06-01

FDA issued a Form 483 to Valentini Italian Specialties, Co. on 2017-06-01 with 16 public-safe observations.

483· Form 483 issuedFoods & Cosmetics16 observations

Valentini Italian Specialties, Co. · Miami, United States · Issued June 1, 2017

Overview

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

Inspectional observations

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

1 Jun 2017
21 CFR 110.10(b)(6)

Effective use of hair restraint

Cited by John J Bernal, Anabel Veiga, Alexander B Anderson

1 Jun 2017
21 CFR 110.10(b)(6)

Effective use of hair restraint

Cited by John J Bernal, Anabel Veiga, Alexander B Anderson

1 Jun 2017
21 CFR 110.10(b)(6)

Effective use of hair restraint

Cited by John J Bernal, Anabel Veiga, Alexander B Anderson

1 Jun 2017
21 CFR 110.37(b)(3)

As source of contamination

Cited by John J Bernal, Anabel Veiga, Alexander B Anderson

1 Jun 2017
21 CFR 110.37(b)(3)

As source of contamination

Cited by John J Bernal, Anabel Veiga, Alexander B Anderson

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(6)Cited across public-safe Form 483 observations4x
21 CFR 110.37(b)(3)Cited across public-safe Form 483 observations4x
21 CFR 110.37(e)Cited across public-safe Form 483 observations4x
21 CFR 110.40(b)Cited across public-safe Form 483 observations4x

Full 483 report

Get the verbatim text of all 16 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