Issued: 12/13/11
Region: Northeast
Category: Device 483s
Inspection date range: 12/5/11-12/13/11
Pages: 4
Company: Advanced Monitored Caregiving
11 John St.
Ste. 250
New York, NY 10038
Inspector(s): Ronald Ifraimov
Observations: A device history record has not been maintained, procedures for design control have not been established and procedures for corrective and preventive action have not been established.
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