Atlas

Form 483

Boehringer Ingelheim Pharmaceuticals, Inc. Form 483, 2017-07-28

FDA issued a Form 483 to Boehringer Ingelheim Pharmaceuticals, Inc. on 2017-07-28 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Boehringer Ingelheim Pharmaceuticals, Inc. · Ridgefield, United States · Issued July 28, 2017

Overview

  • 3 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 Jul 2017
21 CFR 314.80(b)

Failure to develop written procedures

Cited by Christopher Janik

28 Jul 2017
21 CFR 314.80(b)

Failure to review ADE information

Cited by Christopher Janik

28 Jul 2017
21 CFR 314.80(c)(1)(i)

Late submission of 15-day report

Cited by Christopher Janik

Inspected site

BIBoehringer Ingelheim Pharmaceuticals, Inc.Ridgefield, United States

Inspection team

CJChristopher Janik

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 314.80(b)Cited across public-safe Form 483 observations2x
21 CFR 314.80(c)(1)(i)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 observations

The full inspection record, as Atlas holds it, 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