Form 483

Ben Mald Corp. Form 483, 2023-09-19

FDA issued a Form 483 to Ben Mald Corp. on 2023-09-19 with 6 public-safe observations.

483· Form 483 issuedFoods & Cosmetics6 observations

Ben Mald Corp. · Corozal, United States · Issued September 19, 2023

Overview

  • 6 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.

19 Sep 2023
21 CFR 118.4

Written SE plan not implemented/followed

Cited by Moraima J Ramos-Valle

19 Sep 2023
21 CFR 118.4

Written SE plan not implemented/followed

Cited by Moraima J Ramos-Valle

19 Sep 2023
21 CFR 118.8(a)

Method to be used, environmental samples

Cited by Moraima J Ramos-Valle

19 Sep 2023
21 CFR 118.8(a)

Method to be used, environmental samples

Cited by Moraima J Ramos-Valle

19 Sep 2023
FDCA 402(a)(4)

On farm processing of shell eggs

Cited by Moraima J Ramos-Valle

Inspected site

BMBen Mald Corp.Corozal, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 118.4Cited across public-safe Form 483 observations2x
21 CFR 118.8(a)Cited across public-safe Form 483 observations2x
FDCA 402(a)(4)Cited across public-safe Form 483 observations2x

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