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Form 483

Boehringer Ingelheim Pharmaceuticals, Inc. Form 483, 2019-12-12

FDA issued a Form 483 to Boehringer Ingelheim Pharmaceuticals, Inc. on 2019-12-12 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Boehringer Ingelheim Pharmaceuticals, Inc. · Ridgefield, United States · Issued December 12, 2019

Overview

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

Inspectional observations

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

12 Dec 2019
21 CFR 312.50

Ensuring compliance with plan and protocol

Cited by Peter R Lenahan, Cynthia F Kleppinger, Miah Jung

12 Dec 2019
21 CFR 312.56(b)

Notification of FDA of termination of investigator

Cited by Peter R Lenahan, Cynthia F Kleppinger, Miah Jung

12 Dec 2019
21 CFR 312.57(c)

Record retention requirement

Cited by Peter R Lenahan, Cynthia F Kleppinger, Miah Jung

Inspected site

BIBoehringer Ingelheim Pharmaceuticals, Inc.Ridgefield, United States

Inspection team

PRPeter R Lenahan
CFCynthia F Kleppinger
MJMiah Jung

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 312.50Cited across public-safe Form 483 observations1x
21 CFR 312.56(b)Cited across public-safe Form 483 observations1x
21 CFR 312.57(c)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 3 observations

The source PDF, 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