FDA 483 - PIOUS LABORATORIES PRIVATE LIMITED - February 05, 2025

Pious Laboratories Private Limited in Rangwasa, India, was cited for deficiencies in its quality control unit and laboratory controls during an FDA inspection. The firm's Quality Unit failed to identify a significant calculation error during raw material analysis, and the company lacks validated formulas and written procedures for critical analytical calculations for its OTC drug products. These issues indicate a lack of robust quality oversight and control over manufacturing processes.