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Dallas-Area Compounding Pharmacy to Be Inspected for Contamination, Unsanitary Conditions
The Department of Justice (DOJ) has forced a Dallas-area compounding pharmacy to stop producing sterile drugs and face an independent inspection.[1] The DOJ in January filed an injunction against Downing Labs for making contaminated drugs and for unsanitary production conditions. The Food and Drug Administration (FDA) has stepped up its oversight of compounding pharmacies in the wake of a fungal...
Dallas-Area Compounding Pharmacy to Be Inspected for Contamination, Unsanitary Conditions
The Department of Justice (DOJ) has forced a Dallas-area compounding pharmacy to stop producing sterile drugs and face an independent inspection.[1] The DOJ in January filed an injunction against Downing Labs for making contaminated drugs and for unsanitary production conditions. The Food and Drug Administration (FDA) has stepped up its oversight of compounding pharmacies in the wake of a fungal meningitis outbreak in 2012 that was traced to a compounding facility in Massachusetts and sickened more than 750 patients, killing 64.[2]
FDA inspections of Downing Labs in 2013[3] and 2014[4] had identified serious problems in the company’s facilities and procedures for making sterile drugs. A third FDA inspection of Downing Labs in late 2015 again revealed serious deficiencies.[5] These findings finally prompted the FDA to seek DOJ intervention.
References
[1] Associated Press. DOJ forces Texas pharmacy to stop mixing drugs until inspection. CBS News. January 5, 2016. http://www.cbsnews.com/news/doj-forces-texas-pharmacy-to-stop-mixing-drugs-until-expert-inspection/. Accessed January 8, 2016.
[2] Elfin D. Compounder Downing Labs enters Into Consent Decree. Bloomberg BNA: Pharmaceutical Law & Industry Report. January 7, 2016. http://www.bna.com/compounder-downing-labs-n57982065859/. Accessed January 8, 2016.
[3] Food and Drug Administration. Form FDA 483, Inspectional Observations, issued to NuVision Pharmacy. April 17, 2013. http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM348772.pdf. Accessed January 9, 2016.
[4] Food and Drug Administration. Form FDA 483, Inspectional Observations, issued to Downing Labs. July 16, 2014. http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM405669.pdf. Accessed January 9, 2016.
[5] Food and Drug Administration. Form FDA 483, Inspectional Observations, issued to Downing Labs. October 9, 2015. http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM467321.pdf. Accessed January 9, 2016.
