Atlas

Form 483

Boehringer Ingelheim Pharma GmbH and Co. KG Form 483, 2019-09-19

FDA issued a Form 483 to Boehringer Ingelheim Pharma GmbH and Co. KG on 2019-09-19 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Boehringer Ingelheim Pharma GmbH and Co. KG · Biberach An Der Ris, Germany · Issued September 19, 2019

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

19 Sep 2019
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Erika V Butler

19 Sep 2019
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Erika V Butler

19 Sep 2019
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Erika V Butler

Inspected site

BIBoehringer Ingelheim Pharma GmbH and Co. KGBiberach An Der Ris, Germany

Inspection team

EVErika V Butler

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 211.113(b)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited 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