Issued: 11/7/11
Region: Central
Category: Device 483s
Inspection date range: 10/24/11-11/7/11
Pages: 5
Company: Boehringer Laboratories, Inc.
300 Thoms Dr.
Phoenixville, PA 19401-5149
Inspector(s): Michael J. Nerz
Observations: Design validation did not ensure the device conforms to defined user needs and intended uses.
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