FDA EIR - SGS India Private Limited - November 24, 2017

An FDA surveillance inspection of SGS India Private Limited, a contract testing laboratory in Navi Mumbai, India, took place from November 22-24, 2017. Conducted under Compliance Program 7356.002 Drug Manufacturing Inspections, the review focused on the firm's quality and laboratory control systems, including method validation, stability programs, training, equipment qualification, and data archival, to ensure compliance with Good Manufacturing Practices (GMP) for drug products intended for the U.S. market. The inspection specifically noted the firm's previous involvement in analytical method validation data for a U.S. submission. Notably, this inspection concluded with no objectionable conditions identified, and thus, no FDA Form 483 (Inspectional Observations) was issued. This positive outcome follows a previous inspection in February 2016, which had resulted in five violations related to quality control responsibility, documentation of procedures, completeness of laboratory records, employee training, and adherence to the stability program. The FDA verified that SGS India Private Limited had successfully implemented and corrected all previously cited issues. The FDA's conclusion for this inspection was "No Action Indicated" (NAI), with a future re-inspection planned based on CDER risk assessment.