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# CGMP Issues at Bayer Leverkusen
- URL: https://www.fdaweb.com/cgmp-issues-at-bayer-leverkusen/
- Published: 2018-02-13T12:00:00.000Z
- Updated: 2026-09-14T23:22:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140741

A 1/12-1/20/17 FDA inspection at the Bayer Pharma AG drug manufacturing facility in Leverkusen, Germany, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals, according to a just-released 11/14/17 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm595730.htm?ref=fdaweb.com). Specific violations cited in the letter were: 

- failing to establish and follow adequate written procedures for cleaning and maintaining equipment;
- failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
- failing to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products, and that approves or rejects all procedures or specifications affecting the identity, strength, quality, and purity of the drug product; and
- failing to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards.

 The letter acknowledges that the firm began a data remediation program before the inspection and says its action plans need to be revised to include an assessment of additional products.

The company was told to respond with the list of steps taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.