FDA EIR - Liuzhou LMZ Co., Ltd. - July 05, 2019

An FDA inspection of Liuzhou LMZ Co., Ltd., a manufacturer of over-the-counter drugs including LMZ DR Gingiva Fluoride Toothpaste, was conducted from July 1 to July 5, 2019. This initial Good Manufacturing Practice (GMP) inspection identified significant deficiencies across various operational systems. The inspection was performed under Compliance Program 7356.002, Drug Manufacturing Inspections, which governs human OTC drug manufacturers. The main issues, documented on an FDA Form 483, included the company's failure to establish adequate written procedures for equipment maintenance, product stability studies, and environmental monitoring. The inspection also found that growth media used for microbiological testing was not subjected to required growth promotion tests, impacting the reliability of quality control. Furthermore, laboratory controls were deficient, lacking a comprehensive bulk hold time study for the US-marketed product and failing to adhere to proper water testing methods. Data integrity concerns arose from the absence of a second person review for critical laboratory raw data and equipment calibration records. Production areas showed equipment cleaning issues, with visible residues in dispensing stations, posing contamination risks. Finally, batch records lacked essential calculations for theoretical and actual product yields, hindering process control. The inspection was classified as Voluntary Action Indicated (VAI). Company President, Mr. Kun Wu, committed to submitting a written response to the FDA within 15 business days, outlining corrective actions to address these observed deviations from regulatory standards.