FDA WARNING_LETTER - Sichuan Deebio Pharmaceutical Co. Ltd. - September 08, 2023

The FDA inspected Sichuan Deebio Pharmaceutical Co. Ltd. in China from September 4-8, 2023, revealing significant Current Good Manufacturing Practice (CGMP) deviations for active pharmaceutical ingredients (API), rendering them adulterated under 21 U.S.C. 351(a)(2)(B). Key violations included the failure to follow and document laboratory controls contemporaneously, specifically concerning microbiological plate readings where personnel admitted to relying on memory. The firm's quality unit also failed to exercise its responsibility to ensure API compliance with CGMP, demonstrating deficiencies in investigations and document control. Overall, the firm's quality systems were deemed inadequate, and its quality system did not adequately ensure data accuracy and integrity. The company's initial response was insufficient, lacking details on retrospective reviews of documentation and investigations. The FDA acknowledged the firm's commitment to suspend production of (b)(4), USP API for the U.S. market and strongly recommended engaging a qualified CGMP consultant. The firm must provide a written response within 15 working days detailing corrective actions, with potential consequences including import alerts and refusal of new application approvals if deficiencies are not fully addressed.