Form 483

G. Pohl-Boskamp GmbH & Co. KG Form 483, 2010-11-05

FDA issued a Form 483 to G. Pohl-Boskamp GmbH & Co. KG on 2010-11-05 with 4 public-safe observations.

483· Form 483 issued4 observations

G. Pohl-Boskamp GmbH & Co. KG · Hohenlockstedt, Germany · Issued November 5, 2010

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

5 Nov 2010
21 CFR 211.68(a)

Written calibration / inspection records not kept

Cited by Farhana Khan

5 Nov 2010
21 CFR 211.100(b)

Procedure Deviations Recorded and Justified

Cited by Farhana Khan

5 Nov 2010
21 CFR 211.192

Written record of investigation incomplete

Cited by Farhana Khan

5 Nov 2010
21 CFR 211.198(a)

Complaint Handling Procedure

Cited by Farhana Khan

Inspected site

GPG. Pohl-Boskamp GmbH & Co. KGHohenlockstedt, Germany

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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