Issued: 9/7/11
Region: Southeast
Category: Device 483s
Inspection date range: 8/31/11-9/7/11
Pages: 4
Company: Endotec, Inc.
300 Sunport Ln.
Ste. 500
Orlando, FL 32809-8123
Inspector(s): Richard K. Vogel
Observations: Process control procedures that describe any process controls necessary to ensure conformance to specifications have not been adequately established.
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.