Atlas

Form 483

EMPWR Netherlands BV Form 483, 2018-06-20

FDA issued a Form 483 to EMPWR Netherlands BV on 2018-06-20 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

EMPWR Netherlands BV · Leerdam, Netherlands · Issued June 20, 2018

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.

20 Jun 2018
21 CFR 117.35(a)

Sanitary Operations - Plant Sanitation

Cited by Moraima J Ramos-Valle

20 Jun 2018
21 CFR 117.80(a)

Plant Operations - precautions

Cited by Moraima J Ramos-Valle

Inspected site

ENEMPWR Netherlands BVLeerdam, Netherlands

Inspection team

MJMoraima J Ramos-Valle

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.35(a)Cited across public-safe Form 483 observations1x
21 CFR 117.80(a)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