Different forms of FDA inspection

By Dhansukh Viradiya

Purpose of different FDA forms:

➡️In simply, It is communication documents between companies and FDA. 

➡️Its way to highlight and communication of different issues at different stages of inspection. 

➡️So, lets begin with different forms... 

1. Form FDA 482 

➡️This form also known as notice of  inspection form. 

➡️It is an official notice for inspection signed by FDA officials. 

➡️Inspection coordinator will received notice and manage the inspection accordingly.

➡️The investigator will present credentials and "Notice of Inspection" upon arriving at your plant. 

➡️Inspector having right to come in your manufacturing area and to inspect manufacturing activity, discuss with process involving person, can review online record.

2. Form FDA 483

➡️Form FDA 483 called as "Inspectional Observations," is a form used by the FDA to document and communicate concerns discovered during inspections.

➡️In every form 483 it states 

... lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency determination regarding your compliance. 

➡️Response must be submitted within 15 business days regardless of the number of observations. 

➡️Your responses must be comprehensive, well-reasoned, well-documented, each observation must be addressed individually and take a corrective actions if required and within timeline. 

➡️Often good response can usually help a company to avoid receiving a warning letter, plant shut-down  and any withholding of product approval. 

➡️Corrective actions or procedural changes that were accomplished immediately in the presence of investigator are regarded as positive indications of your concern and desire to voluntarily correct discrepancies.

➡️ If you do not agree with the actions being taken by the FDA or if you have a question about the jurisdiction of the agency in a particular matter, you can contact the FDA office. 

3. Form FDA 484

➡️Form FDA 484 is also called as receipt of samples. 

➡️During inspection, if inspector want to take a sample then they have to issue receipt of those sample on form 484.

➡️Also they have to mention quantity and lot no. of issued samples. 

➡️This form is only applicable for issue sample not for promotional materials, photographs, labels and other record. 

About the Author:

Dhansukh Viradiya is a highly accomplished expert in the pharmaceutical and biopharmaceutical industries. With over 10 years of experience in the field, he has gained comprehensive knowledge and expertise in various areas, including Process Validation, Cleaning Validation, Quality Management System, In-process quality assurance, Qualification etc.

Mr. Dhansukh holds a Master's degree in Pharmacy from a renowned University, where he specialized in Quality Assurance. 

As a thought leader, Mr. Dhansukh has published numerous articles and white papers on various topics related to pharmaceutical and biopharmaceutical industries. His research work focuses on emerging trends, current regulatory expectations, advancements in technology, personalized medicine, and the intersection of healthcare and technology.

With his passion for improving patient care and dedication to advancing the field, Dhansukh Viradiya continues to make significant contributions to the pharmaceutical and biopharmaceutical industries. His insights and expertise make him a valuable resource in understanding the dynamic landscape of these sectors and their impact on global healthcare.

Disclaimer:

The author's biography is provided for informational purposes only and does not imply any endorsement or affiliation with the article or its content.