http://www.fda.gov/ en 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 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 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 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 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 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 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 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 http://www.fda.gov/about-fda/fda-commissioner/snf-holdings-llc-livonia-mi-483-issued-03022023 Task Description Request Please post to the ORA Electronic Reading Room<br /> Record Date 03/02/2023<br /> Short Title (70 char) SNF Holdings LLC, Livonia, MI. 483 issued 03/02/2023<br /> FEI Number 3021886842<br /> Firm Name SNF Holdings LLC<br /> Record Type 483<br /> State MI<br /> Establishment Type Non Sterile Drug Producers Thu, 11 May 2023 11:41:04 EDT FDA http://www.fda.gov/about-fda/fda-commissioner/snf-holdings-llc-livonia-mi-483-issued-03022023 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 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 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 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 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 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 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 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 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 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 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