FDA 483 - SMS Pharmaceutical Limited - Unit VII - December 12, 2025

From December 8 to December 12, 2025, the U.S. Food and Drug Administration (FDA) conducted a regulatory inspection of the SMS Pharmaceuticals Limited, Unit-VII facility located in Andhra Pradesh, India. As a manufacturer of active pharmaceutical ingredients (APIs), the facility is required to maintain strict quality control standards to ensure the safety and purity of its products. The inspection resulted in a Form FDA 483, which highlighted a critical deficiency in the firm’s laboratory operations. Specifically, the investigator found that the company failed to follow its own scientifically sound specifications for testing extraneous matter. In one instance involving a batch of Ibuprofen USP destined for the United States market, the firm reported a passing result despite test data showing a particle count that exceeded established limits and should have been recorded as a failure. This suggests that the firm’s quality oversight is insufficient to guarantee that only compliant materials are distributed. To address these findings, SMS Pharmaceuticals must provide a written response to the FDA. This response should include either a justification for the current practices or a detailed corrective action plan outlining how the company will fix these testing discrepancies and prevent future occurrences. Failure to resolve these issues could lead to further regulatory action by the FDA.