ORA FOIA Electronic Reading Room RSS Feed http://www.fda.gov/ en BayCare Integrated Service Center LLC / dba BayCare Central Pharmacy, Temple Terrace, FL. 483 issued 06/02/2023 http://www.fda.gov/about-fda/fda-commissioner/baycare-integrated-service-center-llc-dba-baycare-central-pharmacy-temple-terrace-fl-483-issued Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 06/02/2023<br /> Short Title (70 char) BayCare Integrated Service Center LLC, Temple Terrace, FL. 483 issued 06/02/2023<br /> FEI Number 3013023419<br /> Firm Name BayCare Integrated Service Center<br /> Record Type 483<br /> State FL<br /> Establishme Fri, 28 Jul 2023 13:46:39 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/baycare-integrated-service-center-llc-dba-baycare-central-pharmacy-temple-terrace-fl-483-issued Central Admixture Pharmacy Services, Allentown, PA. 483 issued 03/30/2023 http://www.fda.gov/about-fda/fda-commissioner/central-admixture-pharmacy-services-allentown-pa-483-issued-03302023 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 03/30/2023<br /> Short Title (70 char) Central Admixture Pharmacy Services, Allentown, PA. 483 Response issued 03/30/2023<br /> FEI Number 3009590582<br /> Firm Name Central Admixture<br /> Record Type 483<br /> State PA<br /> Establishment Ty Thu, 27 Jul 2023 12:14:56 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/central-admixture-pharmacy-services-allentown-pa-483-issued-03302023 Healthy Choice Compounding Pharmacy, LLC. Elmsford, NY. Untitled Letter issued 07/15/2022 http://www.fda.gov/about-fda/fda-commissioner/healthy-choice-compounding-pharmacy-llc-elmsford-ny-untitled-letter-issued-07152022 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 07/15/2022<br /> Short Title (70 char) Healthy Choice Compounding Pharmacy, LLC. Elmsford, NY. Untitled Letter issued 07/15/2022<br /> FEI Number 3013118095<br /> Firm Name Healthy Choice<br /> Record Type Untitled Letter<br /> State NY<br /> Establish Wed, 19 Jul 2023 10:38:14 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/healthy-choice-compounding-pharmacy-llc-elmsford-ny-untitled-letter-issued-07152022 Hiers Enterprises, LLC dba Northwest Compounding Pharmacy. Roseburg, OR. State Referral Letter issued 06/30/2023 http://www.fda.gov/about-fda/fda-commissioner/hiers-enterprises-llc-dba-northwest-compounding-pharmacy-roseburg-or-state-referral-letter-issued Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 06/30/2023<br /> Short Title (70 char) Hiers Enterprises, LLC. Roseburg, OR. SRL issued 06/30/2023<br /> FEI Number 3014745182<br /> Firm Name Hiers Enterprises<br /> Record Type State Referral Letter<br /> State OR<br /> Establishment Type Producer of Wed, 19 Jul 2023 10:36:27 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/hiers-enterprises-llc-dba-northwest-compounding-pharmacy-roseburg-or-state-referral-letter-issued Sentara Infusion Services, Chesapeake, VA. 483 issued 12/16/2022 http://www.fda.gov/about-fda/fda-commissioner/sentara-infusion-services-chesapeake-va-483-issued-12162022 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 12/16/2022<br /> Short Title (70 char) Sentara Infusion Services, Chesapeake, VA. 483 issued 12/16/2022<br /> FEI Number 3011627411<br /> Firm Name Sentara<br /> Record Type 483<br /> State VA<br /> Establishment Type Producer of Sterile Drug Products Wed, 19 Jul 2023 10:24:34 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/sentara-infusion-services-chesapeake-va-483-issued-12162022 SCA Pharmaceuticals LLC, Little Rock, AR. 483 issued 05/17/2023 http://www.fda.gov/about-fda/fda-commissioner/sca-pharmaceuticals-llc-little-rock-ar-483-issued-05172023 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 05/17/2023<br /> Short Title (70 char) SCA Pharmaceuticals LLC, Little Rock, AR. 483 issued 05/17/2023<br /> FEI Number 3010683157<br /> Firm Name SCA Pharmaceuticals<br /> Record Type 483<br /> State AR<br /> Establishment Type Outsourcing Facility Wed, 19 Jul 2023 10:11:31 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/sca-pharmaceuticals-llc-little-rock-ar-483-issued-05172023 Palisades Compounding Pharmacy, Pacific Palisades, CA. 483 issued 03/15/2023 http://www.fda.gov/about-fda/fda-commissioner/palisades-compounding-pharmacy-pacific-palisades-ca-483-issued-03152023 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 03/15/2023<br /> Short Title (70 char) Palisades Compounding Pharmacy, Pacific Palisades, CA. 483 issued 03/15/2023<br /> FEI Number 3008174851<br /> Firm Name Palisades Compounding Pharmacy<br /> Record Type 483<br /> State CA<br /> Establishment Type Thu, 13 Jul 2023 11:31:07 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/palisades-compounding-pharmacy-pacific-palisades-ca-483-issued-03152023 Fresenius Kabi Compounding LLC. Canton, MA. 483 issued 03/06/2023 http://www.fda.gov/about-fda/fda-commissioner/fresenius-kabi-compounding-llc-canton-ma-483-issued-03062023 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 03/06/2023<br /> Short Title (70 char) Fresenius Kabi Compounding LLC. Canton, MA. 483 issued 03/06/2023<br /> FEI Number 3013438665<br /> Firm Name Fresenius Kabi<br /> Record Type 483<br /> State MA<br /> Establishment Type Outsourcing Facility Thu, 13 Jul 2023 11:28:27 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/fresenius-kabi-compounding-llc-canton-ma-483-issued-03062023 Apollo Care LLC, Columbia, MO. 483 issued 04/05/2023 http://www.fda.gov/about-fda/fda-commissioner/apollo-care-llc-columbia-mo-483-issued-04052023 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 04/05/2023<br /> Short Title (70 char) Apollo Care LLC. 483 issued 04/05/2023<br /> FEI Number 3013927023<br /> Firm Name Apollo Care LLC<br /> Record Type 483<br /> State MO<br /> Establishment Type Outsourcing Facility Thu, 13 Jul 2023 11:11:08 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/apollo-care-llc-columbia-mo-483-issued-04052023 MSLS LLC dba The Medicine Shoppe, Lees Summit, MO. 483 issued 09/28/2022 http://www.fda.gov/about-fda/fda-commissioner/msls-llc-dba-medicine-shoppe-lees-summit-mo-483-issued-09282022 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 09/28/2022<br /> Short Title (70 char) MSLS LLC, Lees Summit, MO. 483 issued 09/28/2022<br /> FEI Number 3012814943<br /> Firm Name MSLS LLC dba The Medicine Shoppe<br /> Record Type 483<br /> State MO<br /> Establishment Type Non Sterile Drug Producer Thu, 06 Jul 2023 10:21:00 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/msls-llc-dba-medicine-shoppe-lees-summit-mo-483-issued-09282022 First Royal Care Co. LLC dba Red Mountain Compounding, Mesa, AZ. State Referral Letter issued 02/13/2023 http://www.fda.gov/about-fda/fda-commissioner/first-royal-care-co-llc-dba-red-mountain-compounding-mesa-az-state-referral-letter-issued-02132023 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 02/13/2023<br /> Short Title (70 char) First Royal Care Co. LLC, State Referral Letter issued 02/13/2023<br /> FEI Number 3015235235<br /> Firm Name First Royal Care Co. LLC dba Red Mountain Compounding<br /> Record Type State Referral Lett Thu, 06 Jul 2023 10:19:00 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/first-royal-care-co-llc-dba-red-mountain-compounding-mesa-az-state-referral-letter-issued-02132023 Maimonides Medical Center - Pharmacy. Brooklyn, NY. 483 issued 03/09/2023 http://www.fda.gov/about-fda/fda-commissioner/maimonides-medical-center-pharmacy-brooklyn-ny-483-issued-03092023 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 03/09/2023<br /> Short Title (70 char) Maimonides Medical Center - Pharmacy. 483 issued 03/09/2023<br /> FEI Number 3015468054<br /> Firm Name Maimonides Medical Center<br /> Record Type 483<br /> State NY<br /> Establishment Type Sterile and Non Steri Thu, 06 Jul 2023 10:11:37 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/maimonides-medical-center-pharmacy-brooklyn-ny-483-issued-03092023 Burt's Pharmacy LLC, Newbury Park, CA. State Referral Letter issued 05/23/2023 http://www.fda.gov/about-fda/fda-commissioner/burts-pharmacy-llc-newbury-park-ca-state-referral-letter-issued-05232023 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 05/23/2023<br /> Short Title (70 char) Burt&#039;s Pharmacy LLC, Newbury Park, CA. State Referral Letter issued 05/23/2023<br /> FEI Number 3011924560<br /> Firm Name Burt&#039;s Pharmacy LLC<br /> Record Type State Referral Letter<br /> State CA<br /> Establish Wed, 28 Jun 2023 10:57:15 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/burts-pharmacy-llc-newbury-park-ca-state-referral-letter-issued-05232023 Prisma Health Outsourcing Facility, Simpsonville, SC. 483 issued 03/03/2023 http://www.fda.gov/about-fda/prisma-health-outsourcing-facility-simpsonville-sc-483-issued-03032023 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 03/03/2023<br /> Short Title (70 char) Prisma Health Outsourcing Facility. 483 issued 03/03/2023<br /> FEI Number 3015162096<br /> Firm Name Prisma Health<br /> Record Type 483<br /> State SC<br /> Establishment Type Outsourcing Facility Wed, 28 Jun 2023 10:45:37 EDT FDA http://www.fda.gov/about-fda/prisma-health-outsourcing-facility-simpsonville-sc-483-issued-03032023 CareFirst Specialty Pharmacy LLC, Mount Laurel, NJ. State Referral Letter issued 03/31/2023 http://www.fda.gov/about-fda/fda-commissioner/carefirst-specialty-pharmacy-llc-mount-laurel-nj-state-referral-letter-issued-03312023 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 03/31/2023<br /> Short Title (70 char) CareFirst Specialty Pharmacy LLC, State Referral Letter issued 03/31/2023<br /> FEI Number 3012258924<br /> Firm Name CareFirst Specialty Pharmacy LLC<br /> Record Type State Referral Letter<br /> State NJ<br /> E Mon, 26 Jun 2023 14:18:02 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/carefirst-specialty-pharmacy-llc-mount-laurel-nj-state-referral-letter-issued-03312023 CareFirst Specialty Pharmacy LLC. Mount Laurel, NJ. 483 Response issued 12/04/2022 http://www.fda.gov/about-fda/fda-commissioner/carefirst-specialty-pharmacy-llc-mount-laurel-nj-483-response-issued-12042022 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 12/04/2022<br /> Short Title (70 char) CareFirst Specialty Pharmacy LLC. 483 Response issued 12/04/2022<br /> FEI Number 3012258924<br /> Firm Name CareFirst<br /> Record Type 483 Response<br /> State NJ<br /> Establishment Type Sterile and Non Sterile Mon, 26 Jun 2023 14:03:04 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/carefirst-specialty-pharmacy-llc-mount-laurel-nj-483-response-issued-12042022 PQ Pharmacy LLC, Brooksville, FL. Amended 483 issued 10/27/2022 http://www.fda.gov/about-fda/fda-commissioner/pq-pharmacy-llc-brooksville-fl-amended-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 LLC, Brooksville, FL. Amended 483 issued 10/27/2022<br /> FEI Number 3017374013<br /> Firm Name PQ Pharmacy<br /> Record Type 483<br /> State FL<br /> Establishment Type Outsourcing Facility Wed, 21 Jun 2023 13:52:22 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/pq-pharmacy-llc-brooksville-fl-amended-483-issued-10272022 iRhythm Technologies Inc, Cypress, CA. 483 issued 08/12/2022 http://www.fda.gov/about-fda/fda-commissioner/irhythm-technologies-inc-cypress-ca-483-issued-08122022 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 08/12/2022<br /> Short Title (70 char) iRhythm Technologies Inc, Cypress, CA. 483 issued 08/12/2022<br /> FEI Number 3021769057<br /> Firm Name iRhythm Technologies<br /> Record Type 483<br /> State CA<br /> Establishment Type Medical Device Manufactur Tue, 13 Jun 2023 09:44:48 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/irhythm-technologies-inc-cypress-ca-483-issued-08122022 Auro Pharmacies Inc., La Habra, CA. State Referral Letter issued 04/06/2023 http://www.fda.gov/about-fda/auro-pharmacies-inc-la-habra-ca-state-referral-letter-issued-04062023 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 04/06/2023<br /> Short Title (70 char) Auro Pharmacies Inc., La Habra, CA. State Referral Letter issued 04/06/2023<br /> FEI Number 3011893599<br /> Firm Name Auro Pharmacies Inc.<br /> Record Type State Referral Letter<br /> State CA<br /> Establishme Tue, 16 May 2023 09:27:29 EDT FDA http://www.fda.gov/about-fda/auro-pharmacies-inc-la-habra-ca-state-referral-letter-issued-04062023 Nephron Pharmaceuticals, Murray, KY. 483 issued 12/02/2022 http://www.fda.gov/about-fda/fda-commissioner/nephron-pharmaceuticals-murray-ky-483-issued-12022022 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 12/02/2022<br /> Short Title (70 char) Nephron Pharmaceuticals, Murray, KY. 483 issued 12/02/2022<br /> FEI Number 3010247115<br /> Firm Name Nephron Pharmaceuticals<br /> Record Type 483<br /> State KY<br /> Establishment Type Sterile and Non Sterile Tue, 16 May 2023 09:23:28 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/nephron-pharmaceuticals-murray-ky-483-issued-12022022