Form 483

F. Rozzo & Sons, Inc. Form 483, 2018-05-15

FDA issued a Form 483 to F. Rozzo & Sons, Inc. on 2018-05-15 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

F. Rozzo & Sons, Inc. · New York, United States · Issued May 15, 2018

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

15 May 2018
21 CFR 123.6(c)(5)

Corrective action plan

Cited by Michael R Dominick

15 May 2018
21 CFR 123.7(a)

Corrective action per predetermined plan

Cited by Michael R Dominick

15 May 2018
21 CFR 123.6(c)(3)

Critical limits

Cited by Michael R Dominick

15 May 2018
21 CFR 123.6(c)(6)

Verification procedures - adequacy

Cited by Michael R Dominick

Inspected site

FRF. Rozzo & Sons, Inc.New York, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.6(c)(3)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(5)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(6)Cited across public-safe Form 483 observations1x
21 CFR 123.7(a)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