Freedom of Information Act (FOIA):
“The Freedom of Information Act (FOIA), 5 U.S.C. 552, is a federal freedom of information law that allows for the full or partial disclosure of previously unreleased information and documents controlled by the United States government.”
If you would like to request specific documents from the FDA you can submit a Freedom of Information (FOI) request. It can be submitted directly to the FDA via mail, fax, or electronically. Please visit this FDA page for additional information. FOIA fees are provided on the FOIA Fees webpage.
Please note that disclosure of trade secret information is prohibited, per the Trade Secrets Act (TSA), 18. U.S.C. 1905. Per the FDA’s Trade Secrets webpage, trade secrets include such things as a company’s manufacturing process and precise product formulations. As such, while you may submit a request for such information via FOIA, such information might be prohibited from public disclosure if it is determined by FDA to be trade secret or confidential commercial or financial information, within the meaning of 21 CFR 20.62. Please refer to 21 CFR 20.61 for details about the meaning of what the FDA considers confidential information.
If in the process of doing FOI you are asked to list the address of the facility you are requesting information from, you can use the Establishment Registration and Listing database. Through a search of the database, you can obtain the establishment name, the locations and addresses of currently registered facilities, registration number, and other information. Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the U.S. are required to register annually with the FDA. This process is known as establishment registration (21 CFR Part 807).
For instance, a search of the database using the search term Allergan (in the Establishment Name field) found seven establishments: Allergan Costa Rica, Allergan France, Allergan CA/USA, Allergan TX/USA, Allergan Ireland, Allergan TX/USA, and Allergan, Inc. CA/USA. If you click on the hyperlinks provided in the database for those names, the database will provide you with more detailed information about the establishment, including the address and a listing of the medical devises at the establishment.
Please note, however, that the database only lists currently registered facilities. If your implant was manufactured several years ago in another facility that is no longer registered, the database does not contain historical registration information to allow you to determine the location of such a facility.
However, you might be able to find historical facility location information via the online Inspection Classification Database. For instance, a search using the term Allergan (in the Firm Name field) found several historical listings of inspections and other information ranging from 2008 to 2015. While the information is somewhat limited (to City, State, and Zip Code), it might be sufficient for the information needed for a FOI request.
There is also the online ORA Electronic Reading Room for copies of ORA records, such as Establishment Inspection Reports (EIRs), 483s, 483 Responses, Investigation Memos, Consumer Complaint Records, and others. To see a full listing of the various types of records that are available, please click on the down-arrow located within the Filter by Record Type: field. Please note that some records may be redacted to remove non-pulic information (see 21 CFR Part 20).
Questions relating to FOI requests may be addressed to the Division of Freedom of Information Offices at (301) 796-3900.