Atlas

Form 483

MILEEVEN LTD. Form 483, 2017-04-12

FDA issued a Form 483 to MILEEVEN LTD. on 2017-04-12 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

MILEEVEN LTD. · Piltown, Ireland · Issued April 12, 2017

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.

12 Apr 2017
21 CFR 110.35(d)(1)

Wet cleaning

Cited by Cornelius O Brown

12 Apr 2017
21 CFR 111.20(h)

Physical plant - screening against pests

Cited by Cornelius O Brown

Inspected site

MLMILEEVEN LTD.Piltown, Ireland

Inspection team

COCornelius O Brown

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.35(d)(1)Cited across public-safe Form 483 observations1x
21 CFR 111.20(h)Cited 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