Company: Aventis Behring L.L.C.
Product: Biological products
Product category: Human Drugs
Failure to exercise appropriate controls over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel [21 CFR 211.68(b)] in that changes were not implemented to restrict access and entry of data by Chiron Behring employees after they were no longer entering sterility testing results into Aventis Behring’s laboratory information management system (LIMS).
FDA District: Rockville, Maryland