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Pall GMP corrections must be certified by outside consultant -- FDA warning letter.

This article was originally published in The Gray Sheet

Executive Summary

PALL CORP. PROCEDURES FOR DETERMINING "SIGNIFICANT" PROCESS CHANGES should be established in written documents, FDA says in a Feb. 2 warning letter to the company. During a Dec. 4-14 inspection of the firm's Fajardo, Puerto Rico facility, FDA inspectors found that there was not "any procedure that defined, or described by example, what constitutes a `significant' change" to manufacturing process or materials, the letter says.
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