Boehringer Ingelheim Pharma GmbH and Co. KG
FDA inspection history in Ingelheim am Rhein, Germany, 2013 to 2018
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2013: one warning letter; 2018: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2013One warning letter, at Ingelheim am Rhein, Germany.
- 2018One Form 483, at Ingelheim am Rhein, Germany.
Cited most
Across all Boehringer Ingelheim Pharma GmbH and Co. KG observations on file
- 21 CFR 211.188Batch production and control records3
- 21 CFR 211.182Equipment cleaning and use log1
- 21 CFR 211.192Production record review1
The complete Boehringer Ingelheim Pharma GmbH and Co. KG file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Ingelheim am Rhein, Germany
One Form 483 and one warning letter · 2013 to 2018 · 6 observations
Latest: Form 483, May 4, 2018 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-05-04 | 483 Form 483 | Ingelheim am Rhein, Germany | 6 | $99 |
| 2013-05-06 | Warning letter Warning letter | Ingelheim am Rhein, Germany | — | $99 |
Investigators on these documents
FEI number 3002806556 · most recent document May 4, 2018
About Boehringer Ingelheim Pharma GmbH and Co. KG
How many FDA Form 483s has Boehringer Ingelheim Pharma GmbH and Co. KG received?
FDA Intel has 1 Form 483 on file for Boehringer Ingelheim Pharma GmbH and Co. KG; the most recent is dated May 4, 2018.
When was Boehringer Ingelheim Pharma GmbH and Co. KG last inspected by FDA?
The most recent FDA inspection document on file for Boehringer Ingelheim Pharma GmbH and Co. KG is a Form 483 dated May 4, 2018, for the site in Ingelheim am Rhein, Germany.
What did FDA cite at Boehringer Ingelheim Pharma GmbH and Co. KG?
The regulations cited most in the observations on file for Boehringer Ingelheim Pharma GmbH and Co. KG are 21 CFR 211.188 (Batch production and control records), 3 times; 21 CFR 211.182 (Equipment cleaning and use log), 1 time; 21 CFR 211.192 (Production record review), 1 time.
Has Boehringer Ingelheim Pharma GmbH and Co. KG received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Boehringer Ingelheim Pharma GmbH and Co. KG; the most recent is dated May 6, 2013.