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Emergent BioSolutions' Baltimore manufacturing facility failed to meet Current Good Manufacturing Practice (CGMP) requirements for finished pharmaceutical drugs, rendering their products adulterated. FDA investigators documented significant violations including failure to adequately clean, maintain, sanitize, and sterilize equipment, as well as deficient design and control of manufacturing systems that resulted in particulate contamination (including metal particles) in sterile drug products identified through customer complaints. The facility's procedures for equipment cleaning and maintenance did not conform to regulatory standards, and the firm lacked suitable equipment controls necessary for aseptic manufacturing operations.