Drug factory · FDA FEI 3002806462

Bayer AG

Kaiser-Wilhelm-Allee 101-103, Leverkusen, Germany

What it does, for whom

FDA inspection history

What inspectors wrote down

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Jul 27, 2020 inspection

• Control procedures to monitor and validate performance 21 CFR 211.110(a)
  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.
• Prevention of cross contamination, mix-ups 21 CFR 211.130(a)
  There is insufficient physical or spatial separation from operations and other drug products to prevent mix-ups and cross-contamination.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  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.
• Written record of investigation incomplete 21 CFR 211.192
  Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.
• Written procedures fail to include 21 CFR 211.67(b)
  Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used.

Mar 22, 2019 inspection

• Identification of containers, lines, equipment 21 CFR 211.105(a)
  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.
• Control procedures to monitor and validate performance 21 CFR 211.110(a)
  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.
• Labels and labeling stored separately 21 CFR 211.122(d)
  Labels and other labeling materials are not stored separately with suitable identification for each different drug product, strength, dosage form or quantity of contents.
• Following/documenting laboratory controls 21 CFR 211.160(a)
  Established laboratory control mechanisms are not followed.
• Prepared for each batch, include complete information 21 CFR 211.188
  Batch production and control records do not include complete information relating to the production and control of each batch.
• Written procedures fail to include 21 CFR 211.67(b)
  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.

Registered with FDA for: analysis; api manufacture; label; manufacture; pack; particle size reduction.