FDA 483 - Noble Panacea Labs, Inc. - November 08, 2024

From November 4-8, 2024, FDA investigators Rowena S Nguyen and Rachel C Stanton inspected Noble Panacea Labs, Inc., a manufacturer located at 28 Hammond Ste E, Irvine, CA 92618-1661. The inspection identified 11 observations regarding the firm's compliance with Good Manufacturing Practices (GMP) for drug products, specifically concerning their OTC drug product, The Energist Multi-Defense Cream Broad Spectrum Sunscreen SPF 50 (1.1mL).

Key observations include:

1. **Lack of Established Written Procedures for Production and Process Controls:** * No process validation for The Energist Multi-Defense Cream Broad Spectrum Sunscreen SPF 50 (1.1mL). * Water system (NPL-EQ-[b][4]) not validated or adequately monitored; issues with testing frequency justification, unqualified personnel for microbial testing, and lack of microbial testing in qualification reports. This water was used in manufacturing two bulk lots. * Inadequate cleaning validation reports (VAL-03-00, VAL-04-00) for the [b][4] and sachet filling machines, lacking justification for product selection, demonstration of API removal (zinc oxide), and comprehensive cleaning verification tests. * Absence of procedures for using rejected finished product, testing raw materials, 100% finished product inspection, annual product