Get Establishment Inspection Report - Fda

The Establishment Inspection Report (EIR) is a vital document used by the FDA to summarize the findings from inspections of drug manufacturing facilities. This guide aims to help users navigate the online process of filling out the EIR with clarity and precision, ensuring compliance with FDA regulations.

Follow the steps to successfully complete the Establishment Inspection Report online.

1. Click ‘Get Form’ button to obtain the form and open it in the editor.
2. Review the introductory sections and administrative data, including the firm's name, address, and phone numbers. Ensure that all information is current and accurate.
3. Navigate to the 'Summary' section to capture key inspection findings. Summarize the current inspection details including dates and any notable observations.
4. Complete the 'Administrative Data' section by detailing the inspection dates, participants involved, and the firm's responsibilities within the context of the inspection.
5. Fill out the 'History' section, providing relevant background information about the firm, its operations, and previous FDA interactions.
6. Proceed to the 'Individual Responsibility and Persons Interviewed' section, documenting the individuals interviewed during the inspection and their respective roles.
7. In the 'Objectionable Conditions and Management's Response' section, list any issues identified during the inspection and the firm's responses to those findings.
8. Complete the relevant sections on complaints, recall procedures, and any samples collected or additional information, ensuring all observations are documented accurately.
9. Finally, review the entire form for completeness and accuracy. Save changes, and then opt to download, print, or share the completed document as necessary.

Start filling out the Establishment Inspection Report online to ensure compliance and facilitation of the inspection process.