Bayer AG
Overview
Bayer AG is a global enterprise with core competencies in the Life Science fields of healthcare and agriculture. As a leading pharmaceutical company, Bayer develops and manufactures a wide range of healthcare products. Nexavar, an anticancer drug, is developed under Bayer's pharmaceuticals division.
Therapeutic areas
FDA compliance signals
19 FDA enforcement records linked to this company.
- 4832020-07-27
Written record of investigation incomplete
- 4832020-07-27
Scientifically sound laboratory controls
- 4832020-07-27
Prevention of cross contamination, mix-ups
- 4832020-07-27
Written procedures fail to include
- 4832020-07-27
Control procedures to monitor and validate performance
- 4832019-09-24
Cleaning System
- 4832019-09-24
Written procedures not established/followed
- 4832019-09-24
Top/Middle/Bottom container sampling
- 4832019-03-22
Prepared for each batch, include complete information
- 4832019-03-22
Control procedures to monitor and validate performance
- 4832019-03-22
Following/documenting laboratory controls
- 4832019-03-22
Labels and labeling stored separately
- 4832019-03-22
Written procedures fail to include
- 4832019-03-22
Identification of containers, lines, equipment
- warning_letter2017-11-14
FDA Warning Letter (drug product)
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