Last Updated on April 28, 2025 by The Health Master
Establishment Inspection Report (EIR)
Pune-based Emcure Pharmaceuticals Ltd. announced the receipt of the Establishment Inspection Report (EIR) from the United States Food & Drug Administration (USFDA) for their Active Pharmaceutical Ingredient (API) manufacturing plant situated at Kurkumbh, near Pune.
This crucial regulatory clearance signifies that the USFDA has concluded its inspection of the facility, which took place from February 19th to February 25th, 2025.
VAI
The USFDA has classified this inspection as “Voluntary Action Indicated” (VAI).
This classification is an important indicator of the agency’s assessment.
While a VAI designation implies that certain objectionable conditions or practices were identified during the inspection.
It also indicates that the USFDA does not currently intend to recommend any administrative or regulatory enforcement actions based on these findings.
This suggests that Emcure Pharma has either adequately addressed the initial concerns or that the identified issues were not critical.
cGMP
The inspection itself was a detailed evaluation of Emcure regarding the adherence to Current Good Manufacturing Practices (cGMP).
The fact that Emcure’s facility has received an EIR with a VAI status speaks volumes about the company’s commitment to maintaining these stringent quality standards throughout their API manufacturing processes.
Form 483
It’s important to recall that following the inspection, Emcure Pharma had initially received two observations documented in Form 483.
A Form 483 is issued by the USFDA after an inspection to notify that company regarding the violations of the Food, Drug, and Cosmetic Act and related regulations observed during inspections.
Q. What does EIR stand for?
A. EIR stands for Establishment Inspection Report. It is a document issued by the USFDA after an inspection of a pharmaceutical manufacturing facility.
Q. What does VAI mean in the context of a USFDA inspection?
A. VAI stands for Voluntary Action Indicated. It means that the USFDA found objectionable conditions or practices during the inspection, but the agency is not prepared to take or recommend any administrative or regulatory action.
Q. What is Form 483?
A. Form 483 is a document issued by the USFDA to a company at the conclusion of an inspection when investigators have observed any conditions that in their judgment may constitute violations of the Food, Drug, and Cosmetic Act and related Acts.
Q. Is a VAI classification a good outcome?
A. Yes, a VAI classification is generally considered a positive outcome. It indicates that while some issues were noted, they were not severe enough to warrant immediate regulatory action.
Q. What are APIs?
A. APIs stand for Active Pharmaceutical Ingredients. These are the substances within a finished pharmaceutical product that produce the intended effects.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
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