Category: FDA

FOIA Flourish Integrative Pharmacy, LLC of Oklahoma City, OK was issued a 483 on 12/19/2018.  Three Observations were recorded by a single CSO who was on site for four days and who typed the entity as a Producer of Non-Sterile Drugs.  The Observations cited water purity (“Your firm does not perform testing (analytical or microbiological) to …

Late yesterday, around 3 PM in the Eastern Time Zone, news broke that FDA Commissioner Scott Gottlieb has announced his resignation.  This important departure seemed to catch most insiders by total surprise.  One report noted that he had appeared on “Squawk Box” yesterday morning in an interview that seemed like “business as usual.”  His stated …

CIRoA and FOIA No edits since the 2/11/2019 newsletter ROFs ROFs was updated again on 2/19/2019. Three organizations appeared on the list for the first time and I believe all three could be “game-changers,” each in a different way.  Making their debuts on FDA.gov are:Pantheon Labs LLC of Rancho Santa Margarita, CA – Pantheon is a division of …