Form 483

MACAR AND SONS, INC. Form 483, 2023-08-15

FDA issued a Form 483 to MACAR AND SONS, INC. on 2023-08-15 with 6 public-safe observations.

483· Form 483 issuedFoods & Cosmetics6 observations

MACAR AND SONS, INC. · Deerfield Beach, United States · Issued August 15, 2023

Overview

  • 6 public-safe observations are available for this inspection.
  • 6 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 Aug 2023
21 CFR 1.502(b)(1)

LACF compliance

Cited by Carolyn A Ryals

15 Aug 2023
21 CFR 1.504(a)

Hazard analysis written

Cited by Carolyn A Ryals

15 Aug 2023
21 CFR 1.505(a)(2)

Evaluation - performance, risk

Cited by Carolyn A Ryals

15 Aug 2023
21 CFR 1.506(a)(1)

Approved supplier procedures - importer established

Cited by Carolyn A Ryals

15 Aug 2023
21 CFR 1.506(d)(1)(i)

Verification activity assurance

Cited by Carolyn A Ryals

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 1.502(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 1.504(a)Cited across public-safe Form 483 observations1x
21 CFR 1.505(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 1.506(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 1.506(d)(1)(i)Cited across public-safe Form 483 observations1x
21 CFR 1.510(b)(3)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 observations

The full inspection record, as Atlas holds it, 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