ORA FOIA Electronic Reading Room RSS Feed http://www.fda.gov/ en Ajinomoto Althea, Inc. dba Ajinomoto Bio-Pharma Services, San Diego, CA. 483 issued 01/16/2023 http://www.fda.gov/about-fda/fda-commissioner/ajinomoto-althea-inc-dba-ajinomoto-bio-pharma-services-san-diego-ca-483-issued-01162023 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 01/16/2023<br /> Short Title (70 char) Ajinomoto Althea, Inc. San Diego, CA. 483 issued 01/16/2023<br /> FEI Number 3004575449<br /> Firm Name Ajinomoto Althea, Inc.<br /> Record Type 483<br /> State CA<br /> Establishment Type Manufacturer Tue, 25 Apr 2023 15:24:12 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/ajinomoto-althea-inc-dba-ajinomoto-bio-pharma-services-san-diego-ca-483-issued-01162023 Valgene Incorporated dba Cape Drugs, Annapolis, MD. UTL issued 07/20/2022 http://www.fda.gov/about-fda/fda-commissioner/valgene-incorporated-dba-cape-drugs-annapolis-md-utl-issued-07202022 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 07/20/2022<br /> Short Title (70 char) Valgene Incorporated, UTL issued 07/20/2022<br /> FEI Number 3004562873<br /> Firm Name Valgene Incorporated dba Cape Drugs<br /> Record Type UTL<br /> State MD<br /> Establishment Type Sterile and Non Sterile Dru Tue, 25 Apr 2023 10:33:49 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/valgene-incorporated-dba-cape-drugs-annapolis-md-utl-issued-07202022 Valgene Incorporated dba Cape Drugs, Annapolis, MD. UTL follow-up issued 11/03/2022 http://www.fda.gov/about-fda/fda-commissioner/valgene-incorporated-dba-cape-drugs-annapolis-md-utl-follow-issued-11032022 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 11/03/2022<br /> Short Title (70 char) Valgene Incorporated, UTL follow-up issued 11/03/2022<br /> FEI Number 3004562873<br /> Firm Name Valgene Incorporated dba Cape Drugs<br /> Record Type UTL Follow-Up<br /> State MD<br /> Establishment Type Sterile Tue, 25 Apr 2023 10:31:59 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/valgene-incorporated-dba-cape-drugs-annapolis-md-utl-follow-issued-11032022 Valgene Incorporated dba Cape Drugs, Annapolis, MD. UTL response issued 08/31/2022 http://www.fda.gov/about-fda/fda-commissioner/valgene-incorporated-dba-cape-drugs-annapolis-md-utl-response-issued-08312022 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 08/31/2022<br /> Short Title (70 char) Valgene Incorporated, UTL response Issued 08/31/2022<br /> FEI Number 3004562873<br /> Firm Name Valgene Incorporated dba Cape Drugs<br /> Record Type UTL Response<br /> State MD<br /> Establishment Type Sterile a Tue, 25 Apr 2023 10:12:54 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/valgene-incorporated-dba-cape-drugs-annapolis-md-utl-response-issued-08312022 QuVa Pharma, Inc. , Sugar Land, TX. 483 issued 08/18/2022 http://www.fda.gov/about-fda/fda-commissioner/quva-pharma-inc-sugar-land-tx-483-issued-08182022 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 08/18/2022<br /> Short Title (70 char) QuVa Pharma Issued 08/18/2022<br /> FEI Number 3012053582<br /> Firm Name QuVa Pharma, Inc.<br /> Record Type 483<br /> State TX<br /> Establishment Type Outsourcing Facility Wed, 05 Apr 2023 11:13:48 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/quva-pharma-inc-sugar-land-tx-483-issued-08182022 Bond Pharmacy dba Advanced Infusion Solutions, Dallas, TX. 483 issued 01/30/2023 http://www.fda.gov/about-fda/fda-commissioner/bond-pharmacy-dba-advanced-infusion-solutions-dallas-tx-483-issued-01302023 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 01/30/2023<br /> Short Title (70 char) Bond Pharmacy Issued 01/30/2023<br /> FEI Number 3017983596<br /> Firm Name Bond Pharmacy dba Advanced Infusion Solutions<br /> Record Type 483<br /> State TX<br /> Establishment Type Producer of Sterile Drugs Wed, 05 Apr 2023 11:10:16 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/bond-pharmacy-dba-advanced-infusion-solutions-dallas-tx-483-issued-01302023 CareFirst Specialty Pharmacy LLC, Mount Laurel, NJ. 483 issued 11/30/2022 http://www.fda.gov/about-fda/fda-commissioner/carefirst-specialty-pharmacy-llc-mount-laurel-nj-483-issued-11302022 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 11/30/2022<br /> Short Title (70 char) CareFirst Specialty Pharmacy Issued 11/30/2022<br /> FEI Number 3012258924<br /> Firm Name CareFirst Specialty Pharmacy LLC<br /> Record Type 483<br /> State NJ<br /> Establishment Type Producer of non-sterile dru Fri, 24 Feb 2023 14:18:53 EST FDA http://www.fda.gov/about-fda/fda-commissioner/carefirst-specialty-pharmacy-llc-mount-laurel-nj-483-issued-11302022 Randol Mill Pharmacy, Arlington, Texas. SHL issued 09/28/2022 http://www.fda.gov/about-fda/fda-commissioner/randol-mill-pharmacy-arlington-texas-shl-issued-09282022 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 09/28/2022<br /> Short Title (70 char) Randol Mill SHL Issued 09/28/2022<br /> FEI Number 3010177428<br /> Firm Name Randol Mill Pharmacy<br /> Record Type State Handoff Letter<br /> State TX<br /> Establishment Type Producer of Sterile and Non-sterile Fri, 24 Feb 2023 14:14:58 EST FDA http://www.fda.gov/about-fda/fda-commissioner/randol-mill-pharmacy-arlington-texas-shl-issued-09282022 Stokes Healthcare, Inc. dba Epicur Pharma, Mount Laurel, NJ. UTL issued 04/27/2022 http://www.fda.gov/about-fda/fda-commissioner/stokes-healthcare-inc-dba-epicur-pharma-mount-laurel-nj-utl-issued-04272022 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 04/27/2022<br /> Short Title (70 char) Epicur Pharma UTL Issued 04/27/2022<br /> FEI Number 3002815949<br /> Firm Name Stokes Healthcare, Inc. dba Epicur Pharma<br /> Record Type UTL<br /> State NJ<br /> Establishment Type Outsourcing Facility Fri, 24 Feb 2023 12:51:22 EST FDA http://www.fda.gov/about-fda/fda-commissioner/stokes-healthcare-inc-dba-epicur-pharma-mount-laurel-nj-utl-issued-04272022 Barclay, Luke, & Pillai Specialty Pharmacy, PLLC, Las Vegas, NV. 483 issued 12/09/2022 http://www.fda.gov/about-fda/fda-commissioner/barclay-luke-pillai-specialty-pharmacy-pllc-las-vegas-nv-483-issued-12092022 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 12/09/2022<br /> Short Title (70 char) Barclay, Luke, &amp; Pillai Specialty 483 Issued 12/09/2022<br /> FEI Number 3011888866<br /> Firm Name Barclay, Luke, &amp; Pillai Specialty Pharmacy, PLLC<br /> Record Type 483<br /> State NV<br /> Establishment Type Pr Thu, 23 Feb 2023 15:58:37 EST FDA http://www.fda.gov/about-fda/fda-commissioner/barclay-luke-pillai-specialty-pharmacy-pllc-las-vegas-nv-483-issued-12092022 Lynn Oaks Compounding Pharmacy, Thousand Oaks, CA. UTL issued 12/08/2022 http://www.fda.gov/about-fda/fda-commissioner/lynn-oaks-compounding-pharmacy-thousand-oaks-ca-utl-issued-12082022 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 12/08/2022<br /> Short Title (70 char) Lynn Oaks UTL Issued 12/08/2022<br /> FEI Number 3021028639<br /> Firm Name Lynn Oaks Compounding Pharmacy<br /> Record Type Untitled Letter<br /> State CA<br /> Establishment Type Producer of Non-Sterile Drugs Thu, 23 Feb 2023 15:52:01 EST FDA http://www.fda.gov/about-fda/fda-commissioner/lynn-oaks-compounding-pharmacy-thousand-oaks-ca-utl-issued-12082022 Northern VA Compounders PLLC, Sterling, VA. 483 issued 12/09/2022 http://www.fda.gov/about-fda/fda-commissioner/northern-va-compounders-pllc-sterling-va-483-issued-12092022 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 12/09/2022<br /> Short Title (70 char) Northern VA Compounders 483 Issued 12/09/2022<br /> FEI Number 3012590153<br /> Firm Name Northern VA Compounders PLLC<br /> Record Type 483<br /> State VA<br /> Establishment Type Producer of Non Sterile Drugs Tue, 21 Feb 2023 13:02:45 EST FDA http://www.fda.gov/about-fda/fda-commissioner/northern-va-compounders-pllc-sterling-va-483-issued-12092022 Wells Pharma of Houston LLC, Houston, TX. 483 issued 12/14/2022 http://www.fda.gov/about-fda/fda-commissioner/wells-pharma-houston-llc-houston-tx-483-issued-12142022 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 12/14/2022<br /> Short Title (70 char) Wells Pharma of Houston 483 Issued 12/14/2022<br /> FEI Number 3016710931<br /> Firm Name Wells Pharma of Houston LLC<br /> Record Type 483<br /> State TX<br /> Establishment Type Outsourcing Facility Fri, 03 Feb 2023 14:46:40 EST FDA http://www.fda.gov/about-fda/fda-commissioner/wells-pharma-houston-llc-houston-tx-483-issued-12142022 Davis City Pharmacy, Inc., Weatherford, TX. SRL issued 11/30/2022 http://www.fda.gov/about-fda/fda-commissioner/davis-city-pharmacy-inc-weatherford-tx-srl-issued-11302022-0 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 11/30/2022<br /> Short Title (70 char) Davis City SRL Issued 11/30/2022<br /> FEI Number 3016774626<br /> Firm Name Davis City Pharmacy, Inc.<br /> Record Type SRL<br /> State TX<br /> Establishment Type Producer of Non Sterile Drug Products Fri, 03 Feb 2023 14:10:20 EST FDA http://www.fda.gov/about-fda/fda-commissioner/davis-city-pharmacy-inc-weatherford-tx-srl-issued-11302022-0 RC Outsourcing LLC, Lowellville, OH. 483 issued 09/23/2022 http://www.fda.gov/about-fda/fda-commissioner/rc-outsourcing-llc-lowellville-oh-483-issued-09232022 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 09/23/2022<br /> Short Title (70 char) RC Outsourcing Issued 09/23/2022<br /> FEI Number 3011967886<br /> Firm Name RC Outsourcing LLC<br /> Record Type 483<br /> State OH<br /> Establishment Type Outsourcing Facility Fri, 03 Feb 2023 14:06:34 EST FDA http://www.fda.gov/about-fda/fda-commissioner/rc-outsourcing-llc-lowellville-oh-483-issued-09232022 PQ Pharmacy LLC, Brooksville, FL. 483 issued 10/27/2022 http://www.fda.gov/about-fda/fda-commissioner/pq-pharmacy-llc-brooksville-fl-483-issued-10272022 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 10/27/2022<br /> Short Title (70 char) PQ Pharmacy Issued 10/27/2022<br /> FEI Number 3017374013<br /> Firm Name PQ Pharmacy LLC<br /> Record Type 483<br /> State FL<br /> Establishment Type Outsourcing Facility (503B) Mon, 30 Jan 2023 16:06:06 EST FDA http://www.fda.gov/about-fda/fda-commissioner/pq-pharmacy-llc-brooksville-fl-483-issued-10272022 Davis City Pharmacy, Inc., Weatherford, TX. SRL issued 11/30/2022 http://www.fda.gov/about-fda/fda-commissioner/davis-city-pharmacy-inc-weatherford-tx-srl-issued-11302022 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 11/30/2022<br /> Short Title (70 char) Davis City SRL Issued 11/30/2022<br /> FEI Number 3016774626<br /> Firm Name Davis City Pharmacy, Inc.<br /> Record Type SRL<br /> State TX<br /> Establishment Type Producer of Non Sterile Drug Products Mon, 30 Jan 2023 16:00:24 EST FDA http://www.fda.gov/about-fda/fda-commissioner/davis-city-pharmacy-inc-weatherford-tx-srl-issued-11302022 Southern Tier Home Infusion, Inc. dba Pharmacy Innovations, Erie, PA. 483 issued 11/30/2022 http://www.fda.gov/about-fda/fda-commissioner/southern-tier-home-infusion-inc-dba-pharmacy-innovations-erie-pa-483-issued-11302022 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 11/30/2022<br /> Short Title (70 char) Southern Tier Home Infusion Issued 11/30/2022<br /> FEI Number 3004858203<br /> Firm Name Southern Tier Home Infusion, Inc. dba Pharmacy Innovations<br /> Record Type 483<br /> State PA<br /> Establishment Type Pr Mon, 30 Jan 2023 15:54:39 EST FDA http://www.fda.gov/about-fda/fda-commissioner/southern-tier-home-infusion-inc-dba-pharmacy-innovations-erie-pa-483-issued-11302022 First Royal Care Co. LLC, dba Red Mountain Compounding, Mesa, AZ. 483 issued 09/12/2022 http://www.fda.gov/about-fda/fda-commissioner/first-royal-care-co-llc-dba-red-mountain-compounding-mesa-az-483-issued-09122022 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 09/12/2022<br /> Short Title (70 char) First Royal Care Co. LLC 483 Issued 09/12/2022<br /> FEI Number 3015235235<br /> Firm Name First Royal Care Co. LLC, dba Red Mountain Compounding<br /> Record Type 483<br /> State AZ<br /> Establishment Type Produ Mon, 30 Jan 2023 15:12:21 EST FDA http://www.fda.gov/about-fda/fda-commissioner/first-royal-care-co-llc-dba-red-mountain-compounding-mesa-az-483-issued-09122022 Hikma Injectables USA Inc._Dayton_OH. 483 issued 06/08/2022 http://www.fda.gov/about-fda/fda-commissioner/hikma-injectables-usa-inc_dayton_oh-483-issued-06082022 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 06/08/2022<br /> Short Title (70 char) Hikma Injectables Issued 06/08/2022<br /> FEI Number 3022897129<br /> Firm Name Hikma Injectables USA Inc.<br /> Record Type 483<br /> State OH<br /> Establishment Type Outsourcing Facility Wed, 18 Jan 2023 12:17:02 EST FDA http://www.fda.gov/about-fda/fda-commissioner/hikma-injectables-usa-inc_dayton_oh-483-issued-06082022