Atlas

Form 483

Valentini Italian Specialties, Co. Form 483, 2019-08-09

FDA issued a Form 483 to Valentini Italian Specialties, Co. on 2019-08-09 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Valentini Italian Specialties, Co. · Medley, United States · Issued August 9, 2019

Overview

  • 3 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.

9 Aug 2019
21 CFR 110.40(f)

Q.C. instrument accuracy, maintenance

Cited by Neil J Bonzagni

9 Aug 2019
21 CFR 110.80(b)(4)

Preventive control measures

Cited by Neil J Bonzagni

9 Aug 2019
21 CFR 110.93

Storage/transportation of finished goods (contamination)

Cited by Neil J Bonzagni

Inspected site

VIValentini Italian Specialties, Co.Medley, United States

Inspection team

NJNeil J Bonzagni

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.40(f)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.93Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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