Get the free FDA Inspection Report - fda

This FDA inspection report details observations made during the inspection of Haifa Smoked Fish, Inc., including issues related to food safety practices, sanitation controls, and HACCP plan deficiencies.

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 form.
2. Fill in the establishment name and address where the inspection took place.
3. Provide the names and titles of the personnel present during the inspection.
4. Complete the section regarding the purpose of the inspection, such as routine, follow-up, or for cause.
5. Record observations made during the inspection, including any compliance issues.
6. Note any products reviewed and their respective status concerning FDA regulations.
7. Include details of any discussions held with facility management.
8. Document any recommendations or required actions resulting from the inspection.
9. Sign and date the report to confirm its accuracy.

Who needs FDA Inspection Report?

1. Manufacturers and processors of food, drugs, biologics, and medical devices.
2. Designated quality assurance personnel within companies.
3. Regulatory affairs specialists ensuring compliance with FDA standards.
4. Legal counsel when addressing compliance issues.
5. Public health officials monitoring compliance in public health matters.

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If you want to see any unpublished 483, you have to make a special request, which takes time and money.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 created by the Food and Drug Administration following an inspection of a facility to assess compliance with regulatory requirements, including safety, efficacy, and quality standards.

Who is required to file FDA Inspection Report?

Facilities that are subject to FDA inspections, including food production, pharmaceuticals, and medical device manufacturers, are required to maintain and, if necessary, file FDA Inspection Reports.

How to fill out FDA Inspection Report?

To fill out an FDA Inspection Report, an inspector documents observations, findings, deficiencies, and comments regarding compliance with applicable regulations. This typically includes detailed information about the facility, inspection date, observations, and any violations.

What is the purpose of FDA Inspection Report?

The purpose of the FDA Inspection Report is to evaluate compliance with FDA regulations, identify potential violations, and enforce public health standards to ensure the safety and effectiveness of food and medical products.

What information must be reported on FDA Inspection Report?

The FDA Inspection Report must include information such as the facility's name and address, inspection date, name of the inspector, observations of compliance or violations, descriptions of any corrective actions required, and signature of the inspector.