Atlas

Form 483

Rottendorf Pharma Gmbh Form 483, 2017-02-03

FDA issued a Form 483 to Rottendorf Pharma Gmbh on 2017-02-03 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Rottendorf Pharma Gmbh · Ennigerloh, Germany · Issued February 3, 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.

3 Feb 2017
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Nadeem I Chaudhry

3 Feb 2017
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Nadeem I Chaudhry

Inspected site

RPRottendorf Pharma GmbhEnnigerloh, Germany

Inspection team

NINadeem I Chaudhry

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.67(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