Issued: 11/9/11
Region: Northeast
Category: Device 483s
Inspection date range: 11/1/11-11/9/11
Pages: 3
Company: Infimed, Inc.
121 Metropolitan Park Dr.
Liverpool, NY 13088
Inspector(s): Nicholas C Mendiola
Observations: The organizational structure has not been adequately established and maintained to ensure that devices are produced in accordance with 21 CFR 820.
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