FDA WARNING_LETTER - Zhuhai United Laboratories Co. Ltd. - September 15, 2017

The FDA issued a Warning Letter to Zhuhai United Laboratories Co., Ltd. following a September 2017 inspection, citing significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (API). Consequently, the firm's drugs are deemed adulterated under 21 U.S.C. 351(a)(2)(B). Key violations include the failure to adequately investigate and document out-of-specification (OOS) results, lacking scientific justification for invalidations, and an inadequate OOS investigation procedure that permitted inappropriate use of outlier tests. The quality unit also failed to investigate and resolve critical deviations, particularly concerning widespread analytical chromatography data irregularities, such as data deletion and missing audit trails. Further deficiencies were identified in aseptic processing, including failure to maintain electronic data for decontamination cycles, overwriting data, and disabling/modifying electronic audit trails for non-viable particle monitoring, alongside poor aseptic operational behaviors. The FDA concluded that the firm's quality system inadequately ensures data accuracy and integrity. The FDA requires a comprehensive retrospective review of invalidated OOS results, a thorough investigation into data integrity lapses, a risk assessment of their impact on drug quality, and a global corrective and preventive action (CAPA) plan to ensure data reliability across all systems. The letter strongly recommends engaging a qualified CGMP consultant for a comprehensive audit. Failure to correct these deviations may result in refusal of admission of products into the U.S. and withholding of new drug approvals. A response is required within 15 working days.