Establishment Investigation Report (EIR) of FDA

By Dhansukh Viradiya

➡️ In current scenario we have many times hear about  that a company received EIR. some time listen about NAI, VAI and OAI.

➡️ So, we try to clear your doubts of all these FDA inspection report terminology in this article.

➡️ EIR (Establishment Investigation Report) name given by USFDA for an entire data collection of what the FDA inspector did during the time spent at the establishment or facility, from the stage of introductions till the handover of the inspectional observations (called as a form FDA 483).

➡️ The EIR is expected to be a compilation of factual information. 

➡️ If an EIR issued after completion of inspection (without a form FDA 483), it is seen as good for the establishment certified for its intended purpose.

➡️ If the inspection is completed with nos. of inspectional observation, it raises an alarm about something happened wrong.

➡️ The EIR is also created by the Inspector in addition to the form 483. This should be done within 30 working days. The EIR is then examined by the responsible Center or District Office of the FDA, issuing the following statuses: 

1. NAI (No Action Indicated):

➡️There were no objectionable items found during the inspection and is a positive event that means "Facility acceptable".

2. VAI (Voluntary Action Indicated):

➡️ Objectionable items were found, but no action is required on the part of the authority. All of the company's actions are on a voluntary basis. 

➡️ There are also different parts of VAI are... 

• VAI-1=Objectionable condition or practice was corrected during the inspection and the conditions had minimal effect on the integrity (validity of data or rights of research subjects) of the study.

• VAI-2=Objectionable condition or practice has not been corrected during the inspection and the conditions had minimal effect on the integrity of the study. 

• VAI-2C = Only deficiency found was related to an inadequate consent form. 

• VAI-3 = Response to a letter of adverse findings requested or a follow-up inspection initiated. 

• VAI-3R = Response to a letter of adverse findings has been received and accepted. 

• VAI-3F = A follow-up “for cause” inspection initiated.

➡️ A VAI recommendation indicates that the facility needs re-inspection within 12 months at the earliest, but no later than 24 months.

3. OAI (Official Action Indicated):

➡️ Objectionable items were found and further regulatory measures will be derived (e.g. Warning Letter).

➡️ An OAI recommendation rings an alarm bell where warning latter, import ban, consent decrees and forced shutdowns is implement based on criticality untill observations are satisfactory addressed and FDA has verified it through an second time inspection to assure itself of voluntary compliance.

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.