ORA FOIA Electronic Reading Room RSS Feed http://www.fda.gov/ en TMC Acquisition LLC dba Tailor Made Compounding, Nicholasville, KY. 483 issued 03/14/2022 http://www.fda.gov/about-fda/fda-commissioner/tmc-acquisition-llc-dba-tailor-made-compounding-nicholasville-ky-483-issued-03142022 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 03/14/2022<br /> Short Title (70 char) TMC Acquisition 483 Issued 03/14/2022<br /> FEI Number 3012315020<br /> Firm Name TMC Acquisition LLC dba Tailor Made Compounding<br /> Record Type 483<br /> State KY<br /> Establishment Type Producer of Sterile a Fri, 28 Oct 2022 10:13:39 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/tmc-acquisition-llc-dba-tailor-made-compounding-nicholasville-ky-483-issued-03142022 New England Life Care Inc. dba Advanced_Woburn-MA_Form 483_Issued 4-28-2022 http://www.fda.gov/about-fda/fda-commissioner/new-england-life-care-inc-dba-advanced_woburn-ma_form-483_issued-4-28-2022 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 04/28/2022<br /> Short Title (70 char) New England Life Care 483 Issued 04/28/2022<br /> FEI Number 3010371376<br /> Firm Name New England Life Care Inc. dba Advanced<br /> Record Type 483<br /> State MA<br /> Establishment Type Outsourcing Facility Fri, 28 Oct 2022 09:46:10 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/new-england-life-care-inc-dba-advanced_woburn-ma_form-483_issued-4-28-2022 Hikma Injectables USA Inc._Phoenix_AZ. 483 issued 06/08/2022 http://www.fda.gov/about-fda/fda-commissioner/hikma-injectables-usa-inc_phoenix_az-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 NJ<br /> Establishment Type Outsourcing Facility Wed, 19 Oct 2022 16:41:40 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/hikma-injectables-usa-inc_phoenix_az-483-issued-06082022 Compound Preferred LLC, Idaho Falls, ID. 483 issued 12/17/2021 http://www.fda.gov/about-fda/fda-commissioner/compound-preferred-llc-idaho-falls-id-483-issued-12172021 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 12/17/2021<br /> Short Title (70 char) Compound Preferred 483 Issued 03/18/2022<br /> FEI Number 3012465222<br /> Firm Name Compound Preferred LLC<br /> Record Type 483<br /> State ID<br /> Establishment Type Outsourcing Facility Wed, 19 Oct 2022 16:32:57 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/compound-preferred-llc-idaho-falls-id-483-issued-12172021 Central Admixture Pharmacy Services, Inc., Harahan, LA. UTL issued 03/25/2022 http://www.fda.gov/about-fda/fda-commissioner/central-admixture-pharmacy-services-inc-harahan-la-utl-issued-03252022 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 03/25/2022<br /> Short Title (70 char) Central Admixture Issued 03/25/2022<br /> FEI Number 3005292119<br /> Firm Name Central Admixture Pharmacy Services, Inc.<br /> Record Type UTL<br /> State LA<br /> Establishment Type Producer of Sterile Drugs Wed, 19 Oct 2022 16:25:11 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/central-admixture-pharmacy-services-inc-harahan-la-utl-issued-03252022 ImClone Systems, LLC, Branchburg, NJ. 483 issued 08/25/2022 http://www.fda.gov/about-fda/fda-commissioner/imclone-systems-llc-branchburg-nj-483-issued-08252022 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 08/25/2022<br /> Short Title (70 char) ImClone Systems 483 Issued 08/25/2022<br /> FEI Number 3002889358<br /> Firm Name ImClone Systems, LLC<br /> Record Type 483<br /> State NJ<br /> Establishment Type Drug Substance Manufacturer Wed, 19 Oct 2022 16:20:52 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/imclone-systems-llc-branchburg-nj-483-issued-08252022 Catalent Indiana, LLC, Bloomington, IN, FDA Form 483, 8-1-2022 through 9-1-2022 http://www.fda.gov/about-fda/fda-commissioner/catalent-indiana-llc-bloomington-fda-form-483-8-1-2022-through-9-1-2022 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 09/01/2022<br /> Short Title (70 char) Catalent Issued 09/01/2022<br /> FEI Number 3005949964<br /> Firm Name Catalent Indiana, LLC<br /> Record Type 483<br /> State IN<br /> Establishment Type Sterile Human Drug and Biologic Product Manufacturer<br /> Wed, 19 Oct 2022 16:15:31 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/catalent-indiana-llc-bloomington-fda-form-483-8-1-2022-through-9-1-2022 Empower Clinic Services LLC dba Empower Pharmacy, Houston, TX. 483 issued 08/05/2022 http://www.fda.gov/about-fda/fda-commissioner/empower-clinic-services-llc-dba-empower-pharmacy-houston-tx-483-issued-08052022 Record Date 08/05/2022<br /> Short Title (70 char) Empower Clinic Services 483 Issued 08/05/2022<br /> FEI Number 3011887629<br /> Firm Name Empower Clinic Services LLC dba Empower Pharmacy<br /> Record Type 483<br /> State TX<br /> Establishment Type Outsourcing Facility Tue, 11 Oct 2022 11:12:17 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/empower-clinic-services-llc-dba-empower-pharmacy-houston-tx-483-issued-08052022 BioScrip Infusion Services_Augusta, GA_SRL_Issued 4-26-2022 http://www.fda.gov/about-fda/fda-commissioner/bioscrip-infusion-services_augusta-ga_srl_issued-4-26-2022 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 04/26/2022<br /> Short Title (70 char) BioScrip SRL Issued 04/26/2022<br /> FEI Number 3014461693<br /> Firm Name BioScrip Infusion Services<br /> Record Type SRL<br /> State GA<br /> Establishment Type Producer of Sterile and Non-sterile Drugs Tue, 27 Sep 2022 16:16:32 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/bioscrip-infusion-services_augusta-ga_srl_issued-4-26-2022 Potter’s House Apothecary Inc., Peoria, AZ. SRL. SRL Issued 05/16/2022 http://www.fda.gov/about-fda/fda-commissioner/potters-house-apothecary-inc-peoria-az-srl-srl-issued-05162022 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 05/16/2022<br /> Short Title (70 char) Potter’s House Apothecary SRL Issued 05/16/2022<br /> FEI Number 3011701621<br /> Firm Name Potter’s House Apothecary Inc.<br /> Record Type SRL<br /> State AZ<br /> Establishment Type Producer of Sterile and Non- Tue, 27 Sep 2022 16:11:00 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/potters-house-apothecary-inc-peoria-az-srl-srl-issued-05162022 Expert Compounding Pharmacy, Lake Balboa, CA. 483 issued 03/04/2022 http://www.fda.gov/about-fda/fda-commissioner/expert-compounding-pharmacy-lake-balboa-ca-483-issued-03042022-0 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 03/04/2022<br /> Short Title (70 char) Expert Compounding 483 Issued 03/04/2022<br /> FEI Number 3010681729<br /> Firm Name Expert Compounding Pharmacy<br /> Record Type 483<br /> State CA<br /> Establishment Type Producer of Non Sterile Drug Products Tue, 27 Sep 2022 16:04:12 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/expert-compounding-pharmacy-lake-balboa-ca-483-issued-03042022-0 Revive Rx Llc dba Revive Rx Pharmacy_Houston, TX. 483 issued 05/04/2022 http://www.fda.gov/about-fda/revive-rx-llc-dba-revive-rx-pharmacy_houston-tx-483-issued-05042022 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 05/04/2022<br /> Short Title (70 char) Revive Rx LLC 483 Issued 05/04/2022<br /> FEI Number 3016710945<br /> Firm Name Revive Rx LLC<br /> Record Type 483<br /> State TX<br /> Establishment Type Sterile &amp; Non-Sterile Drug Producer Tue, 27 Sep 2022 15:57:04 EDT FDA http://www.fda.gov/about-fda/revive-rx-llc-dba-revive-rx-pharmacy_houston-tx-483-issued-05042022 Westlab Pharmacy Inc. dba Westlab Pharmacy, Gainesville, FL. 483 issued 10/05/2021 http://www.fda.gov/about-fda/fda-commissioner/westlab-pharmacy-inc-dba-westlab-pharmacy-gainesville-fl-483-issued-10052021 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 10/05/2021<br /> Short Title (70 char) Westlab Pharmacy 483 Issued 10/05/2021<br /> FEI Number 3007426960<br /> Firm Name Westlab Pharmacy Inc. dba Westlab Pharmacy<br /> Record Type 483<br /> State FL<br /> Establishment Type Producer of Sterile &amp; Non Tue, 27 Sep 2022 15:42:35 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/westlab-pharmacy-inc-dba-westlab-pharmacy-gainesville-fl-483-issued-10052021 North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding, Richardson, TX. 483 issued 03/10/2022 http://www.fda.gov/about-fda/fda-commissioner/north-american-custom-laboratories-llc-dba-farmakeio-superior-custom-compounding-richardson-tx-483 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 03/10/2022<br /> Short Title (70 char) North American Custom Laboratories 483 Issued 03/10/2022<br /> FEI Number 3014229024<br /> Firm Name North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding<br /> Record Type Tue, 27 Sep 2022 15:14:41 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/north-american-custom-laboratories-llc-dba-farmakeio-superior-custom-compounding-richardson-tx-483 Optum Infusion Services 308, LLC, Chandler, AZ. 483 issued 03/18/2022 http://www.fda.gov/about-fda/fda-commissioner/optum-infusion-services-308-llc-chandler-az-483-issued-03182022 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 03/18/2022<br /> Short Title (70 char) Optum Infusion 483 Issued 03/18/2022<br /> FEI Number 3017600845<br /> Firm Name Optum Infusion Services 308, LLC<br /> Record Type 483<br /> State AZ<br /> Establishment Type Producer of Sterile Drug Products Tue, 27 Sep 2022 13:41:55 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/optum-infusion-services-308-llc-chandler-az-483-issued-03182022 Wedgewood Village Pharmacy, LLC, Swedesboro, NJ. 483 issued 03/24/2022 http://www.fda.gov/about-fda/fda-commissioner/wedgewood-village-pharmacy-llc-swedesboro-nj-483-issued-03242022 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 03/24/2022<br /> Short Title (70 char) Wedgewood Village Pharmacy 483 Issued 03/24/2022<br /> FEI Number 3001779702<br /> Firm Name Wedgewood Village Pharmacy, LLC<br /> Record Type 483<br /> State NJ<br /> Establishment Type Producer of Sterile and No Tue, 27 Sep 2022 13:40:24 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/wedgewood-village-pharmacy-llc-swedesboro-nj-483-issued-03242022 Dorneyville Pharmacy_503A Untitled Letter_Allentown-PA_Issued 03-04-2020 http://www.fda.gov/about-fda/fda-commissioner/dorneyville-pharmacy_503a-untitled-letter_allentown-pa_issued-03-04-2020 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 03/04/2020<br /> Short Title (70 char) Dorneyville Issued 03/04/2020<br /> FEI Number 3005231215<br /> Firm Name Dorneyville Pharmacy<br /> Record Type Untitled Letter<br /> State PA<br /> Establishment Type Producer of Non-Sterile and Sterile Drugs Mon, 26 Sep 2022 16:59:56 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/dorneyville-pharmacy_503a-untitled-letter_allentown-pa_issued-03-04-2020 Delta Pharma, Inc., Ripley, MS. 483 issued 05/20/2022 http://www.fda.gov/about-fda/fda-commissioner/delta-pharma-inc-ripley-ms-483-issued-05202022 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 05/20/2022<br /> Short Title (70 char) Delta Pharma 483 Issued 05/20/2022<br /> FEI Number 3004034796<br /> Firm Name Delta Pharma, Inc.<br /> Record Type 483<br /> State MS<br /> Establishment Type Outsourcing Facility Mon, 26 Sep 2022 16:55:15 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/delta-pharma-inc-ripley-ms-483-issued-05202022 Eagle Pharmacy Inc._503B Untitled Letter_Hoover-AL_Issued 5-17-2022 http://www.fda.gov/about-fda/fda-commissioner/eagle-pharmacy-inc_503b-untitled-letter_hoover-al_issued-5-17-2022 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 05/17/2022<br /> Short Title (70 char) Eagle Pharmacy Inc_UL_Issued 5-17-2022<br /> FEI Number 3011688532<br /> Firm Name Eagle Pharmacy Inc.<br /> Record Type UTL<br /> State AL<br /> Establishment Type Outsourcing Facility Mon, 26 Sep 2022 16:50:00 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/eagle-pharmacy-inc_503b-untitled-letter_hoover-al_issued-5-17-2022 Olympia Compounding Pharmacy dba Olympia Pharmacy, Orlando, FL. 483 issued 03/02/2022 http://www.fda.gov/about-fda/fda-commissioner/olympia-compounding-pharmacy-dba-olympia-pharmacy-orlando-fl-483-issued-03022022 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 03/02/2021<br /> Short Title (70 char) Olympia 483 Issued 03/02/2022<br /> FEI Number 3009724085<br /> Firm Name Olympia Compounding Pharmacy dba Olympia Pharmacy<br /> Record Type 483<br /> State FL<br /> Establishment Type Outsourcing Facility Mon, 26 Sep 2022 16:34:40 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/olympia-compounding-pharmacy-dba-olympia-pharmacy-orlando-fl-483-issued-03022022