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Category: FDA

FDA-Rx – FOIA posted 11 new actions including 7 new 483s.

07/29/2019 by Comply797

April 18, 2019 Edition Sorry to be a week behind on this edition’s action edits which were posted to FOIA April 11.  I love being busy, but with so much turmoil and uncertainty in our field I’ve never been busier! FOIA Peoples Pharmacy, Inc. of Austin, TX was issued an FMD-145 Letter and an SBoP Referral Letter on 03/12/2019, both letters referring …

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FDA-Rx – BREAKING – Paul Elmer, Pharmakon Founder Guilty on 10 Counts

07/30/2019 by Comply797

FOIA was updated today with 12 new actions, but I’m not able to summarize those today due to time constraints.  I will do that as soon as I can, but I wanted to rush this out because I just learned that Paul Elmer, the founder of Indiana’s only Outsourcing Facility to date was found guilty last night in …

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FDA-Rx – BREAKING Gottlieb Statement; 503B Product List; CIRoA edits; FOIA 483s; Dohm to Covington

07/30/2019 by Comply797

CIRoA (All Catch-Up Postings) CIRoA updates since the “Government Shutdown” Barclay Luke & Pillai Specialty Pharmacy PLLC (dba Meta Pharmacy Services), Las Vegas, NV   483 Issued 12/14/2018 Bella Pharmaceuticals, Inc.   Warning Letter (02/11/2019) Brookfield Medical/Surgical Supply, Inc., Brookfield, CT   483 Issued 12/21/2018 Delta Pharma, Inc., Ripley, MS   FDA Press Release: Federal judge enters …

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