Atlas

Form 483

Haupt Pharma Wuelfing GmbH Form 483, 2014-03-28

FDA issued a Form 483 to Haupt Pharma Wuelfing GmbH on 2014-03-28 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Haupt Pharma Wuelfing GmbH · Gronau (Leine), Germany · Issued March 28, 2014

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.

28 Mar 2014
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Nicholas L Paulin

28 Mar 2014
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Nicholas L Paulin

Inspected site

HPHaupt Pharma Wuelfing GmbHGronau (Leine), Germany

Inspection team

NLNicholas L Paulin

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