Novartis Pharma Stein AG – FDA 483, May 9, 2017

Novartis Pharma Stein AG, a drug manufacturer in Stein AG, Switzerland, was inspected by the FDA from May 1-9, 2017. The inspection revealed significant deficiencies across multiple areas, including inadequate laboratory testing and release procedures, insufficient investigations into failed batches, and critical issues with data integrity and equipment calibration. Additionally, the firm failed to prevent microbiological contamination, properly quarantine materials, and assign unique batch numbers, with the latter being a repeat observation.