Issued: 6/24/11
Region: Pacific
Category: Device 483s
Inspection date range: 6/23/11-6/24/11
Pages: 3
Company: Bioteque America, Inc.
2051 Junction Ave.
Suite 128
San Jose, CA 95131-2100
Inspector(s): Christine M. Parmentier
Observations: Procedures have not been established to control product that does not conform to specified requirements.
For unlimited access to our full database of Form 483s please contact customer service toll free at (888) 838-5578 or send an email to customerservice@fdanews.com.