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The Williamsburg Group, LLC - Comment

Document ID: FDA-2007-0614-0003
Document Type: Public Submission
Agency: Food And Drug Administration
Received Date: January 25 2008, at 02:31 PM Eastern Standard Time
Date Posted: January 30 2008, at 12:00 AM Eastern Standard Time
Comment Start Date: December 4 2007, at 12:00 AM Eastern Standard Time
Comment Due Date: February 19 2008, at 11:59 PM Eastern Standard Time
Tracking Number: 803a28d6
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Please see attached comment regarding section 211.113(b). Russell Madsen, The Williamsburg Group, LLC - ...see attached comment regarding section 211.113(b).

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The Williamsburg Group, LLC - Comment

Title:
The Williamsburg Group, LLC - Comment

Abstract:
Russell Madsen, The Williamsburg Group, LLC - Section 211.113(b) has been amended to require validation of all aseptic processes. This codifies a requirement for which currently there is no means to comply. Media fills do not validate aseptic processes.

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