Issued: 1/13/12
Region: Northeast
Category: Device 483s
Inspection date range: 1/9/12-1/13/12
Pages: 2
Company: Nova Biomedical Corp.
200 Prospect St.
Waltham, MA 02453
Inspector(s): Maura Rooney
Observations: Process control procedures that describe any process controls necessary to ensure conformance to specifications have not been adequately established.