Atlas

Form 483

Boehringer Ingelheim Pharmaceuticals, Inc. Form 483, 2010-09-01

FDA issued a Form 483 to Boehringer Ingelheim Pharmaceuticals, Inc. on 2010-09-01 with 3 public-safe observations.

483· Form 483 issued3 observations

Boehringer Ingelheim Pharmaceuticals, Inc. · Ridgefield, United States · Issued September 1, 2010

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

1 Sep 2010
21 CFR 312.50

General responsibilities of sponsors

Cited by M. P Murphy, Michelle M Noe

1 Sep 2010
21 CFR 312.52(a)

Transfer of obligations

Cited by M. P Murphy, Michelle M Noe

1 Sep 2010
21 CFR 312.120(c)

Foreign clinical trials

Cited by M. P Murphy, Michelle M Noe

Inspected site

BIBoehringer Ingelheim Pharmaceuticals, Inc.Ridgefield, United States

Inspection team

MPM. P Murphy
MMMichelle M Noe

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 312.120(c)Cited across public-safe Form 483 observations1x
21 CFR 312.50Cited across public-safe Form 483 observations1x
21 CFR 312.52(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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