Washington / D.C. / Santiago / Toronto / Evanston / Rockville / Liverpool / New York / Washington / DC / /
Company
Gould / PDA Inc. / CDER’s / Northeast Regional Laboratory / Quality Control Laboratories / Microbiological Pharmaceutical Quality Control Laboratories / Sousa S. A. / Class I / L. / /
Country
Canada / United Kingdom / Jamaica / / /
Event
Product Recall / Product Issues / Person Communication and Meetings / /
Facility
One hospital / Cornell University / /
IndustryTerm
Process technologies / manufacturing facility / over-the-counter product / pharmaceutical preservatives / toxic products / pharmaceutical industry / liquid products / drug product / nasal solution / aqueous products / electrolyte solution / sterile pharmaceutical products / drug manufacturing process / pharmaceutical samples / pharmaceutical materials / sterile product / preservative products / chemical preservatives / plastics / final product / pharmaceuticals / process equipment / contaminated commercial product / pharmaceutical manufacturing / manufacturing / pharmaceutical formulations / drug products / hospital equipment / subsequent pharmaceutical recalls / nonsterile products / nutrient-rich media / pharmaceutical manufacturing environments / pharmaceutical product / non-sterile pharmaceutical products / impaired immune systems / contaminated pharmaceuticals / pharmaceutical manufacturer / agriculture products / manufacturing practices / microbial specifications / water systems / violative product / deionized water systems / pharmaceutical purposes / contaminated mouthwash product / drug manufacturing operation / Appropriate manufacturing process improvements / isolation media / pharmaceutical manufacturing areas / incomplete equipment / manufacturing equipment / topical product / pharmaceutical products / manufacturing environments / high-nutrient culture media / /
World Health Organization / American Society for Microbiology / Cornell University / Bureau of Drugs / USP Microbial Limits Chapter / Division of Manufacturing and Product Quality / Food and Drug Administration / office of Compliance / Division of Manufacturing / Center for Drug Evaluation and Research / Department of Health and Human Services / /
Person
Marcel Dekker / Dennis E. Guilfoyle / N. Burkholderia / Microbial Limits / Diane Raccasi / Walter H. Burkholder / Silver Spring / /
Position
president / General / general scientific literature / representative / Archer / pharmaceutical microbiologist / Correspondence author / Microbiologist / /
Downloaded from journal.pda.org on October 6, 2011 Burkholderia cepacia: This Decision Is Overdue Lynn Torbeck, Diane Raccasi, Dennis E. Guilfoyle, et al. PDA J Pharm Sci and Tech 2011, [removed]