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|
|Sanders Pharmaceuticals, Inc. dba Rancho Park Compounding Pharmacy||3005199309||State Referral Letter||California||Producer of Sterile and Non Sterile Drug Products|
|Infusion Treatment Center Inc dba ITC Compounding||3008476140||State Referral Letter||Colorado||Producer of Non Sterile Drug Products|
|Kelley-Ross & Associates, Inc. dba Kelley-Ross Compounding Pharmacy||3013436443||483||Washington||Producer of Sterile and Non Sterile Drug Products|
|Pavilion Compounding Pharmacy||3004570352||Untitled Letter||Georgia||Producer of Sterile Drug Products|
|Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy||3011123993||483||Florida||Producer of Sterile and Non Sterile Drug Products|
|Fresenius Kabi USA LLC||1450022||483||Illinois||Drug Manufacturer|
|Hopkinton Drug, Inc.||3005543749||483||Massachusetts||Producer of Non Sterile Drug Products|
|Thomson International, Inc||3004391505||Investigation Memo||California|
|Thomson International Inc.||3017219425||Investigation Memo||California||Farm|
|Infusion Treatment Center Inc dba ITC Compounding||3008476140||FMD-145 Letter||Colorado||Producer of Non Sterile Drug Products|