Issued: 7/15/11
Region: Northeast
Category: Device 483s
Inspection date range: 6/7/11-7/15/11
Pages: 4
Company: Covidien, LLC
2 Ludlow Park Dr.
Chicopee , MA 01022-1318
Inspector(s): Tamara S. Rosbury
Observations: A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.
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