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# OAI Inspections at U.S. Drug Sites Surpassed India in 2025: Analysis
- URL: https://www.fdaweb.com/oai-inspections-at-u-s-drug-sites-surpassed-india-in-2025-analysis/
- Published: 2026-06-26T12:00:00.000Z
- Updated: 2026-09-14T13:42:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161382

A new analysis of FDA inspection data suggests pharmaceutical manufacturing facilities in the U.S. received a higher proportion of the agency's most serious inspection classification than Indian plants in 2025, marking a reversal from a decade ago. The analysis, authored by **Anil Kumar Angrish** of the National Institute of Pharmaceutical Education and Research in Mohali, India, and co-author **Jatin Babbar**, found that 14.12% of FDA inspections conducted at U.S. pharmaceutical manufacturing facilities in 2025 resulted in an Official Action Indicated (OAI) classification, compared with 7.64% for facilities in India.

An OAI classification indicates FDA believes a facility is in an unacceptable state of compliance and that regulatory or enforcement action may be warranted.

The authors said the findings reflect intensified FDA oversight of domestic manufacturers alongside sustained improvements in regulatory compliance among Indian drug manufacturers. "India hosts the highest number of U.S. FDA-compliant manufacturing facilities outside of the U.S.," the authors wrote, noting the country's growing role in supplying medicines to the American market.

The [report](https://www.thefinancialworld.com/u-s-fda-inspections-of-indian-and-u-s-pharma-sites-a-comparison/?ref=fdaweb.com) comes amid renewed attention to the U.S. pharmaceutical supply chain. According to the authors, about 53% of patented pharmaceutical products distributed in the U.S. are manufactured outside the country, while only about 15% of patented active pharmaceutical ingredients (APIs) used in the U.S. market are produced domestically.

Using FDA inspection data from 2014 through 2025, the authors found that India's share of FDA pharmaceutical inspections has steadily increased as the country's importance to the U.S. drug supply has grown. Indian facilities accounted for 4.48% of FDA pharmaceutical inspections in 2014, rising to 13.5% in 2024 and 13.11% in 2025, they said.

While India's inspection volume increased, its compliance record improved substantially over the same period. The country's OAI rate fell from 21.85% in 2014 — the highest among major pharmaceutical manufacturing countries — to 7.64% in 2025\. The authors noted that India experienced a temporary spike to 44.44% in 2021, although that figure was based on only nine FDA inspections during the pandemic.

By contrast, U.S. manufacturing facilities maintained OAI rates below 10% through 2020 before climbing into double digits beginning in 2021\. The 14.12% rate recorded in 2025 was the highest observed during the 12-year period examined, according to the analysis.