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This document is an inspection report for Peanut Corporation of America, detailing findings from a food safety inspection including compliance with food safety regulations and corrective actions taken.

How to fill out fda inspection report

How to fill out FDA Inspection Report

1. Obtain the FDA Inspection Report form from the FDA website or your regulatory affairs department.
2. Fill in the facility's name, address, and registration number at the top of the form.
3. Indicate the purpose of the inspection, including the specific regulations or compliance areas being assessed.
4. Document the date and time of the inspection, as well as the names and titles of the FDA inspectors involved.
5. Provide a detailed description of the inspection process, including areas inspected and procedures observed.
6. Record any observations, findings, or deviations from acceptable practices during the inspection.
7. Include any recommendations or corrective actions identified by the inspectors, along with timelines for resolution.
8. Conclude with signatures from both the FDA inspectors and a representative from the facility to acknowledge receipt.

Who needs FDA Inspection Report?

1. Manufacturers of food, drugs, medical devices, and cosmetics who are subject to FDA regulations.
2. Companies undergoing routine audits to ensure compliance with FDA standards.
3. Facilities preparing for FDA inspections to ensure all documentation is complete.
4. Regulatory affairs professionals and compliance officers within an organization.
5. Legal teams and consultants advising companies on regulatory 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?

An FDA Inspection Report is a document that summarizes the findings of an inspection conducted by the U.S. Food and Drug Administration to assess a company's compliance with applicable regulations and standards.

Who is required to file FDA Inspection Report?

Firms and organizations subject to FDA regulation, including manufacturers, processors, and distributors of food, drugs, medical devices, and cosmetics, are required to file an FDA Inspection Report if an inspection has taken place.

How to fill out FDA Inspection Report?

To fill out an FDA Inspection Report, the inspected entity must provide detailed information about the inspection date, the inspector's findings, corrective actions taken, and any observed non-compliance issues. The report should be completed clearly and accurately.

What is the purpose of FDA Inspection Report?

The purpose of the FDA Inspection Report is to document compliance with FDA regulations, identify any violations, ensure public health safety, and provide a basis for follow-up actions or further investigations if necessary.

What information must be reported on FDA Inspection Report?

Information that must be reported includes the date of inspection, the name of the individual or organization inspected, detailed observations regarding compliance, corrective actions taken, the names of inspectors, and any violations or deviations noted during the inspection.