Form 483

MACAR AND SONS, INC. Form 483, 2019-03-27

FDA issued a Form 483 to MACAR AND SONS, INC. on 2019-03-27 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

MACAR AND SONS, INC. · Deerfield Beach, United States · Issued March 27, 2019

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

27 Mar 2019
21 CFR 117.206(a)(1)

Modified Requirement Temp Control - Establish Implement

Cited by Marc Balzarini

27 Mar 2019
21 CFR 117.93

Storage and Transportation

Cited by Marc Balzarini

Inspected site

MAMACAR AND SONS, INC.Deerfield Beach, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.206(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.93Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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