Atlas

Form 483

Ben Mald Corp. Form 483, 2020-02-20

FDA issued a Form 483 to Ben Mald Corp. on 2020-02-20 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Ben Mald Corp. · Corozal, United States · Issued February 20, 2020

Overview

  • 4 public-safe observations are available for this inspection.
  • 3 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

20 Feb 2020
21 CFR 118.4

Written SE plan lacks required elements

Cited by Eva I Merced Medina, Sandra Carpio

20 Feb 2020
21 CFR 118.4

Written SE plan not implemented/followed

Cited by Eva I Merced Medina, Sandra Carpio

20 Feb 2020
21 CFR 118.8(a)

Method to be used, environmental samples

Cited by Eva I Merced Medina, Sandra Carpio

20 Feb 2020
FDCA 402(a)(4)

On farm processing of shell eggs

Cited by Eva I Merced Medina, Sandra Carpio

Inspected site

BMBen Mald Corp.Corozal, United States

Inspection team

EIEva I Merced Medina
SCSandra Carpio

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 observations1x
FDCA 402(a)(4)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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