FDA WARNING_LETTER - Guangzhou Four E’s Scientific Co., Ltd. - March 18, 2024

The FDA issued a Warning Letter to Guangzhou Four E’s Scientific Co. Ltd. following a 704(a)(4) records review, identifying significant Current Good Manufacturing Practice (CGMP) violations for its over-the-counter drug products, rendering them adulterated under section 501(a)(2)(B) of the FD&C Act. The primary deficiencies involved the firm's quality control unit (QU) failing to ensure drug products comply with CGMP and meet established specifications (21 CFR 211.22). Specifically, the QU lacked adequate oversight and procedures for its contract manufacturing organization (CMO), which was found to have significant CGMP violations, including inadequate raw material testing, incomplete process validation, and insufficient finished product testing. An example cited was sterile product specifications from the CMO showing microbiological testing not meeting USP <71> sterility requirements. The FDA requires a comprehensive assessment and remediation plan for the QU within 15 working days, addressing procedures, CMO oversight, batch review, investigation approval, and drug product specification evaluation. Failure to correct these violations may result in continued refusal of admission for the firm's products, which were placed on Import Alert 66-40 on October 17, 2024, and potential withholding of new application approvals.