Issued: 6/3/11
Region: Southwest
Category: Drug 483s
Inspection date range: 5/23/11-6/3/11
Pages: 4
Company: Carefusion 213, LLC
1550 Northwestern Dr.
El Paso, TX 79912-8000
Inspector(s): Andrea A. Branche
Lauren E. Skokan
Yvette S. Montes
Observations: An NDA Field Alert Report was not submitted within 3 working days of receipt of information concerning a failure of one or more distributed batches of a drug to meet the specifications established for it in the application.
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