You Have Failed . . . A Case Study in Warning Letter Remediation

Dillon,Ralph;Noferi,Joseph;Arling,Edward;Mikael Blomqvist;

Publication

Article

November 15, 2002

BioPharm International

BioPharm International-11-01-2002

Volume15

Issue 11

You Have Failed . . . A Case Study in Warning Letter Remediation

Author(s):

Ralph L. Dillon,Joseph F. Noferi, Esq.

by Joseph Noferi, Edward R. Arling, Ralph L. Dillon, and Mikael Blomqvist, Pharmacia An FDA Warning Letter can be a business disaster. This case study tracks a company from receipt of an FD 483 ? that did not find contamination, but only the potential for contamination ? to 18 months later when the facility received a clean bill of health. What it did to get there ? and what it learned ? may keep your site from losing its operating freedom.

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Articles in this issue

Outsourcing Outlook: Will CROs find opportunity in a Reinvigorated European R&D Sector?

Inside Washington: Major Changes Ahead for FDA

Bioinformatics Databases ? Questions of Copyright

European Editor's Report ? An Industry Comes of Age

Guest Editorial: Back to the Beginning

Employing Near-Infrared Spectroscopic Methods of Analysis for Fermentation Monitoring and Control: Part 1, Method Development

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