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ORA FOIA Electronic Reading Room Home
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          ORA FOIA Electronic Reading RoomOffice of Regulatory Affairs ORA FOIA Electronic Reading Room
  	
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    PrintThe ORA Electronic Reading Room displays copies of ORA domestic inspection and related records. We are making these records publicly available either (1) proactively at our discretion or (2) because they are "frequently requested" per the Electronic Freedom of Information Act Amendments of 1996. Some records may be redacted to remove non-public information (see 21 CFR Part 20). For publicly available ORA data sets, (such as lists of inspection classifications, 483 observations, etc.), please visit the data sets page. For other ORA documents, please visit the ORA home pageand theFDA Warning Letter page. For foreign inspection and related records, please search the relevant center reading room page on the main FDA Electronic Reading Room.

In the event you are unable to read these documents or portions thereof, please contact ORA’s Division of Information Disclosure Policy ORAOSPOPFOIReadingRoom@fda.hhs.gov. If you are unable to find documents that you are looking for you may file a FOIA request for the records at https://www.fda.gov/regulatory-information/freedom-information/how-make-foia-request.

Content for the ORA FOIA Electronic Reading Room is available on FDA's website for five years before being archived.

To find FOIA archived content for years prior to 2012, visithttps://wayback.archive-it.org/7993/20170404012657/https://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/default.htm.

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            FOIA Record Type
                          - Any -483483 ResponseAdverse Determination LetterAdverse Determination Letter ResponseAmended 483Consent DecreeConsent Decree CorrespondenceConsumer Complaint RecordEstablishment Inspection Report (EIRExhibits and AttachmentsFDA Requested Recall LetterFMD-145 LetterInvestigation MemoMemoOther CorrespondenceRecall RecordReceipt of Payment LetterResponseResumption of Operations Authorization LetterSample RecordState Referral Letter
                            >Untitled LetterWarning Letter ResponseWorkplan
    
      Company Name
                                                                            Record Date
                                                                            FEI Number
                                                                            Record Type
                                                                            State
                                                                            Establishment Type
                                                                            Publish Date
                                                                            ExcerptMaimonides Medical Center
                                                                                                                                            03/09/2023
                                                                                                                                            3015468054
                                                                                                                                            483
                                                                                                                                            New York
                                                                                                                                            Producer of Sterile and Non Sterile Drug Products
                                                                                                                                            07/06/2023First Royal Care Co. LLC dba Red Mountain Compounding
                                                                                                                                            02/13/2023
                                                                                                                                            3015235235
                                                                                                                                            State Referral Letter
                                                                                                                                            Arizona
                                                                                                                                            Producer of Sterile and Non Sterile Drug Products
                                                                                                                                            07/06/2023MSLS LLC dba The Medicine Shoppe
                                                                                                                                            09/28/2022
                                                                                                                                            3012814943
                                                                                                                                            483
                                                                                                                                            Missouri
                                                                                                                                            Producer of Non Sterile Drug Products
                                                                                                                                            07/06/2023Apollo Care LLC
                                                                                                                                            04/05/2023
                                                                                                                                            3013927023
                                                                                                                                            483
                                                                                                                                            Missouri
                                                                                                                                            Outsourcing Facility
                                                                                                                                            07/13/2023Fresenius Kabi
                                                                                                                                            03/06/2023
                                                                                                                                            3013438665
                                                                                                                                            483
                                                                                                                                            Massachusetts
                                                                                                                                            Outsourcing Facility
                                                                                                                                            07/13/2023Palisades Compounding Pharmacy
                                                                                                                                            03/15/2023
                                                                                                                                            3008174851
                                                                                                                                            483
                                                                                                                                            California
                                                                                                                                            Producer of Non Sterile Drug Products
                                                                                                                                            07/13/2023Wedgewood Village Pharmacy
                                                                                                                                            10/17/2022
                                                                                                                                            3001779702
                                                                                                                                            Warning Letter Response
                                                                                                                                            New Jersey
                                                                                                                                            Producer of Sterile and Non Sterile Drug Products
                                                                                                                                            08/23/2023Delta Pharma
                                                                                                                                            06/02/2023
                                                                                                                                            3004034796
                                                                                                                                            483
                                                                                                                                            Mississippi
                                                                                                                                            Outsourcing Facility
                                                                                                                                            08/23/2023BAYCARE INTEGRATED SERVICE CENTER
                                                                                                                                            06/02/2023
                                                                                                                                            3013023419
                                                                                                                                            483
                                                                                                                                            Florida
                                                                                                                                            Outsourcing Facility
                                                                                                                                            07/28/2023Central Admixture
                                                                                                                                            03/30/2023
                                                                                                                                            3009590582
                                                                                                                                            483
                                                                                                                                            Pennsylvania
                                                                                                                                            Outsourcing Facility
                                                                                                                                            07/27/2023
  
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                                                                                  Content current as of:
      01/25/2024ORA FOIA Electronic Reading Room
 
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