Should the firm respond in writing to FDA after receiving the FDA-483 (Inspectional Observations form)?
Yes, the FDA-483 (Inspectional Observations form) is available, by request, to the general public and industry, including foreign, immediately after issuance through the Freedom of Information Act (FOIA). The Establishment Inspection Report (EIR) is also available, by request, to the general public and industry, including foreign, through the FOIA process once the inspection assignment has been officially closed by FDA. (Information on the FOIA process) Foreign governments, including competent authorities, may contact FDA’s Office of International Programs (OIP) to obtain releasable documents. Please contact the Office of International Programs at 1-301-796-4600 (Tel); 1-301-595-5063 (Fax); or by mail at: 10903 New Hampshire Avenue, Building 31, Silver Spring, MD 20993. (More information on FDA’s Office of International Programs) Additionally, the firm may share this information with entities outside the firm, including the competent authority/government and/or trade associations.
