Get the free FDA Inspection Report - fda

This document summarizes the inspection findings of Haifa Smoked Fish, Inc., highlighting issues related to food safety practices and compliance with HACCP plans during an inspection by FDA inspectors.

How to fill out fda inspection report

How to fill out FDA Inspection Report

1. Begin by entering the date of the inspection at the top of the report.
2. Fill in the name and address of the inspected facility.
3. Provide the name of the inspector and their contact information.
4. Document the purpose of the inspection.
5. List all observed areas and processes that were inspected.
6. Record the findings and observations in detail.
7. Note any violations or issues found during the inspection.
8. Include any corrective actions taken during the inspection.
9. Allow for signatures from the inspector and a representative of the facility.
10. Ensure all information is clear and legible before finalizing the report.

Who needs FDA Inspection Report?

1. Manufacturers of food, drugs, medical devices, and other regulated products.
2. Companies seeking to ensure compliance with FDA regulations.
3. Organizations preparing for FDA audits or inspections.
4. Legal and compliance teams within affected companies.

People Also Ask about

Are FDA inspection reports public?

The OII Electronic Reading Room displays copies of select foreign and domestic inspection and related records. We are making these records publicly available either (1) proactively at our discretion or (2) because they are "frequently requested" per the Electronic Freedom of Information Act Amendments of 1996.

Are FDA establishment inspection reports public?

Are FDA Inspection Reports Public? Yes, FDA inspection reports such as Establishment Inspection Reports (EIRs) can be requested through the Freedom of Information Act (FOIA). However, the process may take time, and certain proprietary information may be redacted.

Are FDA reports public?

The OII Electronic Reading Room displays copies of select foreign and domestic inspection and related records. We are making these records publicly available either (1) proactively at our discretion or (2) because they are "frequently requested" per the Electronic Freedom of Information Act Amendments of 1996.

Are FDA 483 observations public?

If you want to see any unpublished 483, you have to make a special request, which takes time and money. Theoretically, Form FDA 483s are public information and, thus, are available through the FDA's Freedom of Information Act Office. So, any Form FDA 483 can be requested by anyone.

Are FDA reports anonymous?

The FDA will not share your identity or contact information with anyone outside the FDA unless required to do so by law, regulation, or court order.

Where can I find FDA 483 reports?

What are the most common FDA 483 observations? Inadequate or insufficient testing of products or raw materials. Failure to properly handle, store, or label materials. Failure to establish or maintain adequate records or logs. Failure to properly report adverse events or incidents.

What are the 4 types of FDA inspections?

The four different types of FDA inspections are pre-approval inspection, routine inspection, compliance follow-up inspection, and “for cause” inspection. Each is intended to help protect the public from unsafe products, but the focus and expectations of each type of inspection are different.

For pdfFiller’s FAQs

What is FDA Inspection Report?

The FDA Inspection Report is a document generated by the Food and Drug Administration (FDA) following an inspection of a facility to assess compliance with regulatory standards for safety, efficacy, and quality.

Who is required to file FDA Inspection Report?

Entities such as manufacturers, repackagers, distributors, and any facility that is subject to FDA regulations, involving food, drugs, medical devices, and other products under FDA oversight, are required to file or respond to FDA Inspection Reports.

How to fill out FDA Inspection Report?

To fill out the FDA Inspection Report, entities should provide accurate information regarding their facilities, practices, and compliance status, detailing any observations made during the inspection and specifying corrective actions taken or planned if deficiencies are noted.

What is the purpose of FDA Inspection Report?

The purpose of the FDA Inspection Report is to document the findings of an inspection, ensure regulatory compliance, identify any violations, and provide guidance on necessary corrective actions to enhance product safety and effectiveness.

What information must be reported on FDA Inspection Report?

The FDA Inspection Report must include details such as the date and type of inspection, the name and address of the inspected facility, observations made, any deviations from regulations, and required corrective actions.