The 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 page and the FDA 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.
To find FOIA archived content for years prior to 2012, visit https://wayback.archive-it.org/7993/20170404012657/https://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/default.htm.
|Company Name||Record Date||FEI Number||Record Type||State||Establishment Type||Publish Date||Excerpt|
|Tailor Made Compounding, LLC||3012315020||Amended 483||Kentucky||Producer of Sterile Drug Products|
|HV Pharmacy, Inc. dba Hunt Valley PharmaLab||3014616172||State Referral Letter||Maryland||Producer of Sterile and Non Sterile Drug Products|
|Apex Pharmacy, LLC||3012958560||483||West Virginia||Producer of Non Sterile Drug Products|
|SCA Pharmaceuticals, Inc.||3010683157||483||Arkansas||Outsourcing Facility|
|Abilene Nuclear LLC dba National Central Pharmacy||3004819860||483||Texas||Producer of Sterile Drug Products|
|McGuff Compounding Pharmacy Services, Inc.||3005031360||483||California||Producer of Sterile and Non Sterile Drug Products|
|Kohana Pharmacy and Center for Regenerative Medicine, Inc.||3013501947||FMD-145 Letter||California||Producer of Non Sterile Drug Products|
|MPRX, Inc. dba Medical Park Pharmacy||3004102002||483||Texas||Producer of Non Sterile Drug Products|
|Vitalab Pharmacy, Inc. dba Vasco Rx Specialty Pharmacy||3007816026||State Referral Letter||Arizona||Producer of Sterile and Non Sterile Drug Products|
|AcariaHealth Pharmacy, Inc.||3001465817||State Referral Letter||Virginia||Producer of Sterile Drug Products|