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This document lists observations made by the FDA during the inspection of Haifa Smoked Fish, Inc., detailing various violations in the HACCP plan and food safety practices.

How to fill out fda inspection report

How to fill out FDA Inspection Report

1. Start by obtaining the FDA Inspection Report form from the FDA website or your local FDA office.
2. Fill in the date of the inspection at the top of the report.
3. Provide the name and address of the facility being inspected.
4. Enter the name and contact information of the inspector.
5. Document the purpose of the inspection in the designated section.
6. Carefully note any observations made during the inspection, including any violations or non-compliance issues.
7. Include any corrective actions taken during or immediately after the inspection.
8. Sign and date the report at the end, ensuring that all information is accurate.
9. Submit the completed report to the appropriate FDA office as instructed.

Who needs FDA Inspection Report?

1. Food manufacturers and distributors.
2. Pharmaceutical companies.
3. Medical device manufacturers.
4. Biotechnology firms.
5. Anyone subject to FDA regulations and inspections.

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If you want to see any unpublished 483, you have to make a special request, which takes time and money.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 that outlines the findings of inspections conducted by the Food and Drug Administration to ensure compliance with regulatory standards for food, drugs, medical devices, and other products.

Who is required to file FDA Inspection Report?

Organizations and facilities that are subject to FDA inspections, including manufacturers of drugs, medical devices, food establishments, and other regulated entities, are required to file an FDA Inspection Report.

How to fill out FDA Inspection Report?

To fill out an FDA Inspection Report, organizations should gather all pertinent data regarding the inspection, complete all sections of the report accurately, ensure truthfulness in the data provided, and submit the report according to FDA guidelines.

What is the purpose of FDA Inspection Report?

The purpose of the FDA Inspection Report is to document the inspection findings, facilitate compliance verification, identify areas needing improvement, and ensure that products meet safety and effectiveness standards.

What information must be reported on FDA Inspection Report?

The information that must be reported includes the date of inspection, the findings of the inspection, any violations noted, corrective actions taken, and responses from the inspected entity.