Get the free FDA Inspection Report - fda

This document lists inspectional observations made by FDA representatives during an inspection of a food production facility, specifically addressing compliance and health standards.

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 establishment being inspected.
3. Provide the name and title of the FDA inspector conducting the inspection.
4. Enter the purpose of the inspection, such as routine, follow-up, or for cause.
5. Document the areas inspected, including specific departments or processes.
6. Record any observations made during the inspection, noting both compliant and non-compliant items.
7. Indicate any corrective actions required and deadlines for resolution.
8. Include any relevant reports or documents as attachments.
9. Sign and date the report upon completion.
10. Distribute the report to the necessary parties, including management and regulatory compliance departments.

Who needs FDA Inspection Report?

1. Any facility that manufactures, processes, or distributes food, drugs, cosmetics, or medical devices that fall under FDA regulation.
2. Companies undergoing an FDA inspection for compliance verification.
3. Regulatory affairs teams or compliance officers managing quality assurance.
4. Legal teams addressing potential compliance issues or violations.
5. Some stakeholders in supply chains needing to understand regulatory status.

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 after an inspection by the Food and Drug Administration, detailing the findings of compliance or non-compliance with regulations pertaining to food, drugs, medical devices, or other FDA-regulated products.

Who is required to file FDA Inspection Report?

Entities regulated by the FDA, including manufacturers, distributors, and facilities involved in the production of food, drugs, or medical devices, are required to respond to the findings in the FDA Inspection Report.

How to fill out FDA Inspection Report?

To fill out the FDA Inspection Report, one should accurately document observations made during the inspection, describe any violations, provide corrective actions taken, and ensure that all required data and signatures are included.

What is the purpose of FDA Inspection Report?

The purpose of the FDA Inspection Report is to assess compliance with applicable regulations, identify potential risks to public health, and ensure that products are safe and effective for consumer use.

What information must be reported on FDA Inspection Report?

The FDA Inspection Report must include information such as the name and address of the facility, date of inspection, inspection observations, identification of products involved, compliance status, and any corrective actions agreed upon.