Bayer Pharma AG Kaiser-Wilhelm Allee
FDA inspection history in Leverkusen, Germany, 2017 to 2020
- 3
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2017: one warning letter and one Form 483; 2019: one Form 483; 2020: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–20Three Form 483s and one warning letter, at Leverkusen, Germany.
- 2019The longest 483 on file: 6 observations over 5 pages at Leverkusen, Germany.
Cited most
Across all Bayer Pharma AG Kaiser-Wilhelm Allee observations on file
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products2
- 21 CFR 211.160(a)General requirements2
- 21 CFR 211.67(b)Equipment cleaning and maintenance2
- 21 CFR 211.105(a)Equipment identification1
- 21 CFR 211.113Control of microbiological contamination1
The complete Bayer Pharma AG Kaiser-Wilhelm Allee file.
All 4 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
Leverkusen, Germany
Three Form 483s and one warning letter · 2017 to 2020 · 12 observations
Latest: Form 483, Jul 27, 2020 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-07-27 | 483 Form 483 | Leverkusen, Germany | 5 | $99 |
| 2019-03-22 | 483 Form 483 | Leverkusen, Germany | 6 | $99 |
| 2017-11-14 | Warning letter Warning letter | Leverkusen, Germany | — | $99 |
| 2017-01-20 | 483 Form 483 | Leverkusen, Germany | 1 | $99 |
Investigators on these documents
Alan P. Kurtzberg (1)Justin A. Boyd (1)Michael A. Charles (1)Noreen Muniz (1)Wayne D. McGrath (1)
FEI number 3002806462 · most recent document Jul 27, 2020
About Bayer Pharma AG Kaiser-Wilhelm Allee
How many FDA Form 483s has Bayer Pharma AG Kaiser-Wilhelm Allee received?
FDA Intel has 3 Form 483s on file for Bayer Pharma AG Kaiser-Wilhelm Allee; the most recent is dated Jul 27, 2020.
When was Bayer Pharma AG Kaiser-Wilhelm Allee last inspected by FDA?
The most recent FDA inspection document on file for Bayer Pharma AG Kaiser-Wilhelm Allee is a Form 483 dated Jul 27, 2020, for the site in Leverkusen, Germany.
What did FDA cite at Bayer Pharma AG Kaiser-Wilhelm Allee?
The regulations cited most in the observations on file for Bayer Pharma AG Kaiser-Wilhelm Allee are 21 CFR 211.110(a) (Sampling and testing of in-process materials and drug products), 2 times; 21 CFR 211.160(a) (General requirements), 2 times; 21 CFR 211.67(b) (Equipment cleaning and maintenance), 2 times.
Has Bayer Pharma AG Kaiser-Wilhelm Allee received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Bayer Pharma AG Kaiser-Wilhelm Allee; the most recent is dated Nov 14, 2017.