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.
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, 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|
|Nubratori, Inc dba Nubratori Rx||3010166491||483||California||Outsourcing Facility|
|AnazaoHealth Corporation||3011152407||483||Nevada||Outsourcing Facility|
|SBH Medical LTD||3015242029||483||Ohio||Producer of Sterile and Non Sterile Drug Products|
|RXQ Compounding LLC||3011509553||483||Ohio||Outsourcing Facility|
|San Diego Compounding Pharmacy||3006072852||FMD-145 Letter||California||Producer of Non Sterile Drug Products|
|Kalman Health & Wellness, Inc. dba Essential Wellness||3011581046||FMD-145 Letter||Illinois||Producer of Sterile Drug Products|
|Crowder’s Institutional Pharmacy LLC., dba Crowder’s Long-Term Care Pharmacy||3013272453||State Referral Letter||Indiana||Producer of Sterile and Non Sterile Drug Products|
|CSRX Inc. dba Rushmore Compounding Pharmacy||3012088586||Other Correspondence||South Dakota||Producer of Non Sterile Drug Products|
|Insight Pharmaceutical Solutions, LLC, dba Insight Pharmacy||3011925174||State Referral Letter||Pennsylvania||Producer of Sterile and Non Sterile Drug Products|
|Crowder’s Institutional Pharmacy LLC., dba Crowder’s Long-Term Care Pharmacy||3013272453||FMD-145 Letter||Indiana||Producer of Sterile and Non Sterile Drug Products|