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 [email protected]. 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.

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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.

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FOIA Record Type - Any - 483 483 Response Adverse Determination Letter Adverse Determination Letter Response Amended 483 Consent Decree Consent Decree Correspondence Consumer Complaint Record Establishment Inspection Report (EIR Exhibits and Attachments FDA Requested Recall Letter FMD-145 Letter Investigation Memo Memo Other Correspondence Recall Record Receipt of Payment Letter Response Resumption of Operations Authorization Letter Sample Record State Referral Letter >Untitled Letter Warning Letter Response Workplan

Company Name	Record Date	FEI Number	Record Type	State	Establishment Type	Publish Date	Excerpt
Hospira Boulder, Inc.	07/10/2015	3005579246	483	Illinois	Manufacturer	04/19/2019
Hospira Boulder, Inc.	01/04/2012	1925262	483	Kansas	Drug Manufacturer	04/21/2021
Hospira Boulder, Inc.	07/10/2015	3005231248	483	Colorado	Active Pharmaceutical Ingredient Manufacturer	04/19/2019
Pentec Health, Inc.	07/10/2015	3006489293	483	Pennsylvania	Producer of Sterile Drug Products	04/19/2019
The Compounding Shop	07/11/2015	3004668624	483	Florida	Producer of Sterile Drug Products	04/19/2019
The Compounding Shop	07/10/2015	3004668624	483	Florida	Producer of Sterile Drug Products	04/19/2019
Medaus, Inc.	07/10/2015	3001298034	483	Alabama	Producer of Sterile Drug Products	04/19/2019
Specialty Compounding Pharmacy	07/10/2015	3009815000	483	Texas	Producer of Sterile Drug Products	04/19/2019
St. Jude Medical IESD	07/10/2015	2017865	Warning Letter Response	California	Manufacturer	04/19/2019
Foundation Care LLC	07/24/2015	3005364771	483 Response	Maryland	Producer of Sterile Drug Products	04/19/2019

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