The establishment of test procedures and laboratory control mechanisms including any changes thereto, are not drafted by the appropriate organizational unit and reviewed and approved by the quality control unit.
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Germany manufacturing-site findings
at manufacturing sites in this country 51 findings drawn from 13 published documents. The most recent cases are below; the full set is in search.
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Companies with the most findings
Recent findings
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
See every finding in this document View official sourceProcedures describing the handling of all written and oral complaints regarding a drug product are not established and followed.
See every finding in this document View official sourceThe responsibilities and procedures applicable to the quality control unit are not fully followed.
See every finding in this document View official sourceChanges to written procedures are not reviewed and approved by the quality control unit.
See every finding in this document View official sourceFailure to submit biological deviation.
See every finding in this document View official sourceOther countries
These findings are a record of the moment each document was published. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out — do not read them as the current state; check the regulator's official announcements for the latest status. Counts are measured from public data as of 2026-09-04, and findings are extracted automatically from the regulator's published documents. “View official source” on each case links directly to that document.
