Atlas

Form 483

Excella GmbH & Co. KG Form 483, 2012-10-10

FDA issued a Form 483 to Excella GmbH & Co. KG on 2012-10-10 with 2 public-safe observations.

483· Form 483 issued2 observations

Excella GmbH & Co. KG · Feucht, Germany · Issued October 10, 2012

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.

10 Oct 2012
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Sandra A Hughes

10 Oct 2012
21 CFR 211.165(d)

Acceptance criteria for sampling & testing

Cited by Sandra A Hughes

Inspected site

EGExcella GmbH & Co. KGFeucht, Germany

Inspection team

SASandra A Hughes

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.165(d)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)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