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Category: FDA

FDA-Rx – GMP Draft Guidance for 503B-AHA says <797> and <800> need to be delayed-several new 483s

07/30/2019 by Comply797

Thrifty White Drug #762 of Minneapolis, MN was issued a 483 on 9/21/2018 at the end of its first ever FDA Inspection.  Six Observations were recorded by two investigators who were on site for five days and who typed the entity as a Producer of Sterile and Non-sterile Drug Products.  The Observations were those typically cited: …

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