FDA 483s available in the World Wide Web

Recommendation

6/7 May 2021

Live Online Training: Lean GMP-Systems

The Freedom of Information Act (FOIA) allows anyone to request copies of records that are normally not prepared for public distribution. According to the Act, materials and other information have also to be available in publicly accessible "electronic reading rooms" with systems that also allow users to electronically search for files and index materials.

However, not everybody interested in certain documents has the time and possibility to visit these public reading rooms. Thus, documents falling under the FOIA can also be requested in writing. Requesters may have to pay fees covering some or all of the costs of processing their request, and sometimes it may take quite a while to get the document demanded.

A need to know is the fact that the ORA Electronic Reading Room displays copies of certain records. The Office of Regulatory Affairs is making these records publicly available either proactively at ORA's discretion or because they are "frequently requested" per the Electronic Freedom of Information Act Amendments from 1996.

Under the URL http://www.fda.gov/ora/frequent/ everyone can review 483s, Consent Decree Correspondence and other interesting documents providing information on what the FDA expects - helping companies to prepare for an agency inspection.