FDA WARNING_LETTER - Natural Beauty Care Pty Ltd - August 24, 2021

FDA issued a Warning Letter to Natural Beauty Care Pty Ltd, an Australian manufacturer of OTC drug products, following a review of records submitted in response to a Section 704(a)(4) request. The FDA determined that the firm's methods, facilities, or controls do not conform to current Good Manufacturing Practice (CGMP) regulations (21 CFR parts 210 and 211), rendering their drug products adulterated under section 501(a)(2)(B) of the FD&C Act. Significant violations include failure to conduct appropriate finished product testing for identity and strength of active ingredients prior to release (21 CFR 211.165(a)), failure to verify the identity of each component (21 CFR 211.84(d)(1)), and failure to establish an adequate stability testing program (21 CFR 211.166(a)). Additionally, the firm lacks process flow diagrams for critical control points and has inadequate quality systems. The FDA strongly recommended engaging a qualified CGMP consultant to assist in remediation and audit operations. All drug products manufactured by the firm were placed on Import Alert 66-40 on March 23, 2021, meaning they may be detained or refused admission. The firm must respond within 15 working days, detailing corrective actions and a plan to prevent recurrence, with potential re-inspection to verify compliance.