Get the free Form FDA 483 (09/08) Inspectional Observations - Food and Drug ... - fda

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DISTRICT ADDRESS AND PHONE NUMBER Male(S) OF INSPECTION 4040 North Central Expressway, Suite 300 Dallas, TX 75204 (214) 253-5200

How to fill out form fda 483 0908

How to fill out form FDA 483 0908:

1. Begin by carefully reviewing the instructions provided with the form. Familiarize yourself with the purpose of the form and the specific information it requires.
2. Start by entering the necessary identifying information at the top of the form, such as the company name, date of the inspection, the name of the FDA investigator, and the address of the facility.
3. Go through each section of the form systematically, filling in the required information. Pay close attention to detail to ensure accuracy.
4. Provide a brief description or summary of the observations made by the FDA investigator in Section 1. This should include any violations or deviations noted during the inspection.
5. In Section 2, list the specific regulations or standards that have not been met based on the observations made in Section 1. Provide the corresponding page number(s) or document reference(s) where these violations can be found.
6. In Section 3, outline the proposed actions or corrective measures that will be taken to address each violation or deviation. Be clear and concise in explaining how you intend to rectify the non-compliance.
7. If there are any attachments or supporting documents that are relevant to the observations or proposed actions, include them in Section 4.
8. Finally, sign and date the form, certifying that the information provided is complete and accurate.

Who needs form FDA 483 0908?

1. Companies or facilities that have undergone an FDA inspection and have been issued observations or findings of non-compliance may need to fill out form FDA 483 0908.
2. It is primarily intended for use by the FDA investigator to communicate their observations related to the inspection and the identified deviations from regulations or standards.
3. The form serves as a formal record of the inspection, documenting the observations made and providing a framework for the company or facility to address and correct the identified issues.

For pdfFiller’s FAQs

What is form fda 483 0908?

Form FDA 483 is a form used by the Food and Drug Administration (FDA) to document and communicate violations found during inspections of regulated facilities. The 0908 designation refers to the form number specifically for medical device and radiological health inspections.

Who is required to file form fda 483 0908?

Manufacturers of medical devices and facilities involved in radiological health are required to file form FDA 483 0908 if violations are found during FDA inspections.

How to fill out form fda 483 0908?

The form must be completed by the FDA inspector conducting the inspection and must include details of any violations found.

What is the purpose of form fda 483 0908?

The purpose of form FDA 483 0908 is to document and communicate violations found during inspections in order to ensure compliance with FDA regulations.

What information must be reported on form fda 483 0908?

Form FDA 483 0908 must include details of violations found during inspections, including the nature of the violation and any corrective actions required.

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