Last Updated on May 24, 2025 by The Health Master
USFDA
Piramal Pharma received an Establishment Inspection Report from the US Food and Drug Administration (USFDA) for its Turbhe facility, which is a VAI classification, meaning the company has successfully undergone a rigorous Good Manufacturing Practices (GMP) investigation by the US entity and passed.
VAI Relative to EIR from the USFDA
An Establishment Inspection Report (EIR) from the USFDA is the endpoint of any manufacturing company’s journey for those products intended for sale in the domestic marketplace.
An EIR is issued when the USFDA has reviewed findings from its investigatory inspection and either has taken or is taking proper action based on what it’s determined is correct.
Therefore, for Piramal’s Turbhe facility to receive a VAI classification is quite interesting.
A VAI classification notes that the USFDA did find objectionable conditions during the investigatory inspection but in this case does not warrant administrative action at this time.
In effect, this means that while there were some deviations from the norm at Turbhe, they were not significant enough to imply that compliance with established GMPs was ineffective.
Inspection of Piramal Pharma
The inspection happened over one week, from 11 February to 17 February 2025.
The USFDA inspected the facility and issued up to six observations.
Thus, the fact that it closed via EIR with VAI status means compliance with regulatory standards.
The operations of Piramal Pharma
The operations of the company fall under the following major business verticals:
Piramal Pharma Solutions (PPS)
An integrated Contract Development and Manufacturing Organization (CDMO) providing end-to-end solutions across the pharmaceutical product life cycle to innovative pharma and generics players alike. PPS has a globally integrated network of facilities.
Piramal Critical Care (PCC)
An integrated division dedicated to its hospital generics.
PCC’s portfolio comprises various critical care products, including:
- Inhalation anesthetics,
- Intrathecal treatments for spasticity and pain management,
- Injectable pain management and anesthesia agents,
- Injectable anti-infectives, and
- Other adjunctive treatments.
India Consumer Healthcare
This is the business unit championing over-the-counter pharmaceutical options for consumer-led health betterment.
Q. What is USFDA EIR?
A. The Establishment Inspection Report (EIR) is a report created by the USFDA for a firm after an inspection is complete. It details what was discovered during the inspection and the agency’s current stance on whether or not the firm is in compliance.
Q. What does VAI mean?
A. VAI means Voluntary Action Indicated. It is a classification made in an EIR by the USFDA that signifies that objectionable conditions do exist or were seen during the inspection; however, the USFDA is not yet prepared to undertake or suggest any regulatory or administrative action.
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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