FDA 483 - SNJ Labs Pvt. Ltd. - February 06, 2026

From February 2 to February 6, 2026, the U.S. Food and Drug Administration (FDA) conducted an inspection of SNJ Labs Private Ltd., an active pharmaceutical ingredient (API) manufacturer located in Rajkot, Gujarat, India. The inspection revealed several significant failures in the facility"s quality management and data integrity systems. Key issues included the quality unit"s failure to properly investigate and resolve critical laboratory test failures, with the firm often invalidating failing results without conducting adequate risk assessments or performing necessary equipment maintenance. Furthermore, the facility utilized non-validated testing methods that could not reliably detect product degradation over time. Data integrity was a major concern, as investigators found that laboratory staff had unrestricted access to delete or rename electronic data files and could change system dates and times. Additionally, software used for critical calculations remained unvalidated. Physical facility maintenance was also found to be deficient; clean rooms exhibited visible stains, leaks, and rust, contradicting cleaning logs that indicated the areas were maintained. Finally, the firm failed to establish detailed procedures for sampling materials and neglected to document microbiological testing in real-time. This report serves as a formal list of observations and requires SNJ Labs to submit a comprehensive response to the FDA detailing their corrective actions. The company must address these systemic gaps to ensure their manufacturing processes meet international safety and quality standards.