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at manufacturing sites in this country 34 findings drawn from 5 published documents. The most recent cases are below; the full set is in search.
See all France findingsProcedures designed to prevent microbiological contamination ofdmg products purp01ting to be sterile did not include adequate validation of the aseptic process.
See every finding in this document View official sourceAseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
See every finding in this document View official sourceProcedures designed to prevent microbiological contamination ofdmg products purp01ting to be sterile are not established.
See every finding in this document View official sourceThere is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any ofits components to meet any ofits specifications whether or not the batch has been already distiibuted.
See every finding in this document View official sourceWritten procedures ai·e not followed for evaluations conducted at least aimually to review records associated with a representative number ofbatches, whether approved or rejected.
See every finding in this document View official sourceApprop1iate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records ai·e instituted only by authorized personnel.
See every finding in this document View official sourceThese 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.
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