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# FDA Finds 11 Problems at Bayer Facility
- URL: https://www.fdaweb.com/fda-finds-11-problems-at-bayer-facility/
- Published: 2018-02-23T12:00:00.000Z
- Updated: 2026-09-14T23:25:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140831

The just-released FDA-483 issued following a 1/13-1/20/17 inspection at the Bayer Pharma facility in Leverkusen, Germany, that produces parenteral, solid oral dosage, and active pharmaceutical ingredient drugs contains 11 inspection observations. Specific [violations](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM597965.pdf?ref=fdaweb.com) were: 

- failing to ensure appropriate environmental conditions for filling parenteral products;
- failing to establish procedures to ensure reliable detection of particulate matter in parenteral products;
- failing to establish and follow procedures for cleaning of equipment and the facility;
- failing to establish a document control system;
- failing to conduct thorough complaint investigations and extend the investigation to related batches;
- failing to establish separate areas to prevent cross-contamination;
- failing to perform a thorough investigation into a discrepancy;
- failing to have facilities and equipment of a suitable design for their intended use;
- failing to maintain and review all analytical data;
- failing to establish test procedures for analytical testing; and
- · failing to record data contemporaneously.