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

Noble Panacea Labs, Inc., located in Irvine, CA, was inspected by the FDA from November 4 to November 8, 2024. The inspection revealed several critical compliance issues primarily related to manufacturing practices and quality control processes. Key observations include the absence of written procedures for production and process controls, specifically for The Energist Multi-Defense Cream Broad Spectrum Sunscreen SPF 50. The firm failed to validate processes to ensure consistent product quality and did not adequately monitor the water system used in manufacturing, lacking justification for testing frequency and using unqualified methods for microbial testing.

Further violations were noted in cleaning validation processes, where the firm did not justify product selection for validation or demonstrate effective cleaning of active ingredients. Additionally, the inspection highlighted the absence of procedures for handling rejected products, testing raw materials, conducting 100% inspections, and performing annual product reviews.

The plumbing system was found defective, with potential contamination risks due to stagnant water and lack of routine sanitization. Moreover, the firm’s computer systems lacked validation and security controls, with no audit trails or established procedures, posing risks to data integrity.

The FDA requires Noble Panacea Labs to establish and implement corrective actions to address these deficiencies, ensuring compliance with regulatory standards for drug manufacturing and quality assurance. The firm must validate its processes, improve its water and cleaning systems, and secure its data management practices to prevent future violations.