OneSource Specialty Pharma received a USFDA inspection VAI status for its Bengaluru sterile injectables unit on 30 October.

The report follows an inspection of the company’s Sterile Product Division by the US drug regulator between 22 and 30 June 2026.

An Establishment Inspection Report, or EIR, is the formal write-up the regulator issues once an inspection ends.

The inspection ended on 30 June with one observation, which is the term for an issue inspectors flag.

The company said on 2 July that it would respond to the regulator within the set time.

So what does VAI mean? It stands for Voluntary Action Indicated, the middle grade among the regulator’s three possible outcomes.

Inspectors noted some lapses against manufacturing rules, but nothing serious enough to trigger a warning letter or an import ban.

The company is expected to fix the issues on its own. The rating closes the inspection process for this site.

Managing Director and CEO Neeraj Sharma said the result reflects the company’s focus on quality and compliance.

He described the Bengaluru plant as central to its sterile manufacturing for global partners.

The plant makes sterile injectables. These are medicines given by injection, and they have to be produced in germ-free conditions.

It is one of five manufacturing sites OneSource runs, and the firm also works in biologics, drug-device combinations and soft gelatin capsules. The inspection outcome lands days after the company’s September quarter results.

On 27 October, OneSource reported revenue of Rs 516.20 crore, up 37% from a year earlier, while EBITDA, a measure of operating profit, rose 53% to Rs 163.30 crore. The margin widened to 31.6% from 28.3%.

It also began commercial production on a second cartridge line for drug-device combinations, products where a medicine and its delivery device ship together.

During the quarter, it added six new wins and two new customers, taking its client count to over 82, and recorded 12 launches across North America, the Middle East and North Africa and Latin America.

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