Boehringer Ingelheim Pharma GmbH and Co. KG
Form 483 issued May 4, 2018 · Ingelheim am Rhein, Germany
- Inspection
- Apr 30 – May 4, 2018
- Investigator
- Christopher Keating
- Observations
- 6
- Pages
- 2
- FEI number
- 3002806556
In short: On May 4, 2018, FDA issued a Form 483 with 6 observations to Boehringer Ingelheim Pharma GmbH and Co. KG in Ingelheim am Rhein, Rhineland-Palatinate (FEI 3002806556) after an inspection that ran Apr 30 – May 4, 2018. The investigator was Christopher Keating. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.188 (batch production and control records).
At a glance
Production and quality system account for 5 of 6 observations.
Most cited: 21 CFR 211.188 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Records fail to include a complete inventory record of the reconciliation of sealed product containers filled…
- 02
Process validation has not been conducted for recovery of solvent used in the…
- 03
Deviation investigations do not always include appropriate recommended changes, including preventative controls…
- 04
Batch production records fail to include the signature of the person directly supervising or checking each…
This inspection in context
Christopher Keating
13 documents · 2018–2020
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmBoehringer Ingelheim Pharma GmbH and Co. KG history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.188
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Boehringer Ingelheim Pharma GmbH and Co. KG?
FDA listed 6 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.188 (batch production and control records). The opening words of each observation are shown on this page.
Who inspected Boehringer Ingelheim Pharma GmbH and Co. KG?
Christopher Keating is named on this Form 483, for the inspection of Apr 30 – May 4, 2018. Each investigator has a profile showing what they cite most.
When was Boehringer Ingelheim Pharma GmbH and Co. KG inspected by FDA?
The inspection ran Apr 30 – May 4, 2018, and the Form 483 is dated May 4, 2018.
How do I get the full Form 483 for Boehringer Ingelheim Pharma GmbH and Co. KG?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.