FDA 483s and Responses available in the World Wide Web

The Freedom of Information Act (FOIA) allows anyone to request copies of records that are normally not fully prepared for public distribution. According to the Act, materials and other information have 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. But the Office of Regulatory Affairs (ORA) Electronic Reading Room also displays copies of certain records in the World Wide Web. ORA 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 of the ORA FOIA Electronic Reading Room, everyone can review 483s*, 483 responses, Consent Decree Correspondence** and other interesting documents. These may also provide information on what the FDA expects - helping companies to prepare for an inspection by the agency.

*483 is the number of a form used by an FDA Investigator to document the deficiencies he found during an inspection. It is issued at the end of the inspection and should be answered officially. This response is expected within 15 working days after its issuance. Only then it is guaranteed that the statement will be taken into account in a possible Warning Letter.

**If a company has repeatedly violated cGMP requirements, FDA may make a legal agreement to force the company to take specific actions. A Consent Decree can include penalties and due dates for the actions defined. Sometimes a consulting company will check the company and streamline systems and processes. A final inspection is carried out at the end. In the meantime, profits can be skimmed off.