Bayer Pharma AG Kaiser-Wilhelm Allee
Form 483 issued March 22, 2019 · Leverkusen, Germany
- Inspection
- Mar 11 – Mar 22, 2019
- Investigators
- Alan P. Kurtzberg· Noreen Muniz
- Observations
- 6
- Pages
- 5
- FEI number
- 3002806462
In short: On March 22, 2019, FDA issued a Form 483 with 6 observations to Bayer Pharma AG Kaiser-Wilhelm Allee in Leverkusen, NW (FEI 3002806462) after an inspection that ran Mar 11 – Mar 22, 2019. The investigators were Alan P. Kurtzberg and Noreen Muniz. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Established laboratory control mechanisms…
- 02
Labels and other labeling materials are not stored separately with suitable identification for each different drug…
- 03
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment…
- 04
Control procedures are not established which monitor the output of those manufacturing processes that may be…
This inspection in context
Alan P. Kurtzberg
24 documents · 2015–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
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 211.160(a)
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 6 observations on this Form 483, mostly about production, laboratory controls and packaging & labeling. The opening words of each observation are shown on this page.
Who inspected Bayer Pharma AG Kaiser-Wilhelm Allee?
Alan P. Kurtzberg and Noreen Muniz are named on this Form 483, for the inspection of Mar 11 – Mar 22, 2019. Each investigator has a profile showing what they cite most.
When was Bayer Pharma AG Kaiser-Wilhelm Allee inspected by FDA?
The inspection ran Mar 11 – Mar 22, 2019, and the Form 483 is dated March 22, 2019.
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.