Bayer Pharma AG Kaiser-Wilhelm Allee
Form 483 issued July 27, 2020 · Leverkusen, Germany
- Inspection
- Jul 20 – Jul 27, 2020
- Investigators
- Michael A. Charles· Wayne D. McGrath
- Observations
- 5
- Pages
- 9
- FEI number
- 3002806462
In short: On July 27, 2020, FDA issued a Form 483 with 5 observations to Bayer Pharma AG Kaiser-Wilhelm Allee in Leverkusen, NW (FEI 3002806462) after an inspection that ran Jul 20 – Jul 27, 2020. The investigators were Michael A. Charles and Wayne D. McGrath. Most observations concern quality system and production.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up. Investigations…
- 02
EUPLOYEE(S SIGNATURE 51368 Germany Control procedures are not established which monitor the output and validate the…
- 03
There is insufficient physical or spatial separation from operations and other drug products to…
- 04
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods…
This inspection in context
Michael A. Charles
29 documents · 2013–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Colorado.
The firmBayer Pharma AG Kaiser-Wilhelm Allee history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bayer Pharma AG Kaiser-Wilhelm Allee?
FDA listed 5 observations on this Form 483, mostly about quality system, production and packaging & labeling. The opening words of each observation are shown on this page.
Who inspected Bayer Pharma AG Kaiser-Wilhelm Allee?
Michael A. Charles and Wayne D. McGrath are named on this Form 483, for the inspection of Jul 20 – Jul 27, 2020. Each investigator has a profile showing what they cite most.
When was Bayer Pharma AG Kaiser-Wilhelm Allee inspected by FDA?
The inspection ran Jul 20 – Jul 27, 2020, and the Form 483 is dated July 27, 2020.
How do I get the full Form 483 for Bayer Pharma AG Kaiser-Wilhelm Allee?
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.