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FDA establishment 3002806462, Leverkusen, Germany. Part of Bayer's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations, and the shipments FDA refused at the border.
Inspections: 10
Official action indicated: 2
Last inspection ended: Mar 20, 2025
Warning letters: 1
Import refusals since 2024: 6
Inspections by Fiscal Year
FY2018 to FY2027 to date; 1 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
21 CFR 211.130(a). Prevention of cross contamination, mix-ups There is insufficient physical or spatial separation from operations and other drug products to prevent mix-ups and cross-contamination.
21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
21 CFR 211.67(b). Written procedures fail to include Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used.
21 CFR 211.192. Written record of investigation incomplete Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.
21 CFR 211.110(a). Control procedures to monitor and validate performance Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
Voluntary Action Indicated (VAI)
Mar 22, 2019
Drugs · Drug Quality Assurance
6 cited references
21 CFR 211.188. Prepared for each batch, include complete information Batch production and control records do not include complete information relating to the production and control of each batch.
21 CFR 211.160(a). Following/documenting laboratory controls Established laboratory control mechanisms are not followed.
21 CFR 211.105(a). Identification of containers, lines, equipment All processing lines and major equipment used during the production of a batch of drug product is not properly identified at all times to indicate contents and the phase of processing of the batch.
21 CFR 211.122(d). Labels and labeling stored separately Labels and other labeling materials are not stored separately with suitable identification for each different drug product, strength, dosage form or quantity of contents.
21 CFR 211.67(b). Written procedures fail to include Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used and parameters relevant to the operation.
21 CFR 211.110(a). Control procedures to monitor and validate performance Control procedures are not established which monitor the output of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
Official Action Indicated (OAI)
Jan 20, 2017
Drugs · Drug Quality Assurance
None posted
Official Action Indicated (OAI)
Jun 3, 2016
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Nov 14, 2014
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Jul 9, 2012
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Feb 23, 2010
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Warning Letters
Letters naming this establishment; each opens the letter
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard and warning letters
Leverkusen, Germany. Part of