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Biotech / Medical : SNRS- Sunrise Technologies

SNRS 0.000001000

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Jun 6 11:01 AM EST

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To: BusterB12 who wrote (3790)	1/27/2000 10:27:00 AM
From: Joe	Read Replies (1) of 4140

Russ continues to deliver as promised. Another points on ISO 9001. The certification requires an extensive quality system which is the same that is required by FDA. Sunrise still is required to undergo FDA's GMP or Good Manufacturing Practices inspection. It is required prior to FDA's final approval of the PMA. Well what FDA requires in this inspection is almost exactly the same as required of ISO 9001. While FDA will not accept the ISO certification as a substitute for their own inspection, it reaffirms my belief that SNRS will pass the GMP inspection with flying colors. Joe

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