FDA 483 - The Skin Atelier, Inc. - July 26, 2024

An FDA inspection conducted at The Skin Atelier, Inc. from July 22-26, 2024, revealed significant deficiencies in its operations as an OTC drug manufacturer. The observations, documented on an FDA Form 483, highlight critical issues in the firm's quality system, particularly concerning contract operations. The company's quality control unit lacked proper oversight for drug products manufactured and tested by external contractors, failing to establish written procedures for supplier qualification or adequately qualify contract packagers. Furthermore, essential quality management procedures were either absent or not followed, including those for deviations and investigations, annual product reviews (none performed since March 2020), change control, and corrective and preventive actions. The absence of change control and CAPA procedures was a repeat observation from prior inspections in 2019 and 2021, indicating a persistent systemic issue. Additional concerns included the lack of adequate long-term stability data to justify expiration dates for products like Radiance Shield UVA/UVB Sunscreen SPF 44 and Spot on Acne Treatment. The firm also failed to properly manage reserve samples, lacking written procedures for their annual visual inspection, performing no such inspections, and maintaining insufficient quantities for complete testing. These observations indicate non-compliance with regulatory expectations for Good Manufacturing Practices, requiring The Skin Atelier, Inc. to implement comprehensive corrective actions to ensure product quality and regulatory adherence.