FDA 483 - Naturich Cosmetique Labs - May 02, 2025

During an inspection conducted from April 28 to May 2, 2025, the FDA issued a Form 483 to a pharmaceutical manufacturing firm in Dallas, Texas, citing significant deviations from Current Good Manufacturing Practices (cGMP) for over-the-counter (OTC) drug products. Key violations include a lack of established control procedures and process validation for multiple OTC drug products like baby diaper cream and hand sanitizer, a repeat observation from 2020. The firm’s water system qualification was deficient, lacking critical conductivity and total organic carbon testing.

Furthermore, the company failed to thoroughly investigate numerous unexplained discrepancies and out-of-specification (OOS) results. This included widespread objectionable microbial contamination in the water system with gram-negative organisms, impacting products released to clients. Investigations into OOS results for Titanium Dioxide in SPF 30 lotion and Salicylic Acid in acne moisturizer were insufficient, with affected batches approved for release without determining root causes or potential impact on other products.

Component testing was found to be deficient, with the firm relying solely on supplier certificates of analysis for glycerin and failing to test alcohols for methanol content. Batch production records were incomplete, lacking consistent documentation of significant manufacturing steps, a recurring issue since 2015. Annual Product Reviews were deficient, not including OOS investigations, and not performed annually as required. Lastly, equipment cleaning validation studies lacked scientific justification for product selection and specific swab locations.

These observations require the firm to implement comprehensive corrective and preventive actions to ensure compliance with cGMP regulations and uphold product quality and patient safety.