Get the free FDA Inspection Report - fda

This document details the observations made during an inspection of a medical device manufacturer by the Food and Drug Administration (FDA), highlighting various compliance issues and quality system

How to fill out fda inspection report

How to fill out FDA Inspection Report

1. Begin by clearly stating the date and time of the inspection.
2. Enter the name and address of the facility being inspected.
3. Fill out the name and title of the FDA inspector.
4. Describe the type of inspection (e.g., routine, follow-up, etc.).
5. List the specific products or processes being inspected.
6. Document the findings, including any violations or issues noted.
7. Include a section for the facility’s response to the findings.
8. Sign and date the report, ensuring all required signatures are present.

Who needs FDA Inspection Report?

1. Manufacturers and distributors of food, drugs, and medical devices.
2. Businesses seeking FDA approval for their products.
3. Companies under investigation for compliance issues.
4. Regulatory affairs professionals managing compliance documentation.

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If you want to see any unpublished 483, you have to make a special request, which takes time and money.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 summarizes the findings of an FDA inspection at a facility that is regulated by the Food and Drug Administration.

Who is required to file FDA Inspection Report?

Entities that are subject to FDA inspections, such as food manufacturers, drug companies, and medical device producers, are required to file the FDA Inspection Report.

How to fill out FDA Inspection Report?

To fill out the FDA Inspection Report, the responsible party must provide accurate information regarding the facility, inspection findings, and any corrective actions taken in response to the inspection.

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, and outline necessary corrective actions to ensure public health and safety.

What information must be reported on FDA Inspection Report?

The FDA Inspection Report must include details such as facility identification, inspection date, observations made during the inspection, compliance status, and any corrective actions required.