U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, College Park, MD, USA.
U.S. Food and Drug Administration, Office of Emergency Operations, Silver Spring, MD, USA.
Epidemiol Infect. 2022 Aug 4;150:e154. doi: 10.1017/S0950268822000668.
In March 2018, the US Food and Drug Administration (FDA), US Centers for Disease Control and Prevention, California Department of Public Health, Los Angeles County Department of Public Health and Pennsylvania Department of Health initiated an investigation of an outbreak of complex () infections. Sixty infections were identified in California, New Jersey, Pennsylvania, Maine, Nevada and Ohio. The infections were linked to a no-rinse cleansing foam product (NRCFP), produced by Manufacturer A, used for skin care of patients in healthcare settings. FDA inspected Manufacturer A's production facility (manufacturing site of over-the-counter drugs and cosmetics), reviewed production records and collected product and environmental samples for analysis. FDA's inspection found poor manufacturing practices. Analysis by pulsed-field gel electrophoresis confirmed a match between NRCFP samples and clinical isolates. Manufacturer A conducted extensive recalls, FDA issued a warning letter citing the manufacturer's inadequate manufacturing practices, and federal, state and local partners issued public communications to advise patients, pharmacies, other healthcare providers and healthcare facilities to stop using the recalled NRCFP. This investigation highlighted the importance of following appropriate manufacturing practices to minimize microbial contamination of cosmetic products, especially if intended for use in healthcare settings.
2018 年 3 月，美国食品和药物管理局（FDA）、美国疾病控制与预防中心、加利福尼亚州公共卫生部、洛杉矶县公共卫生部和宾夕法尼亚州卫生部对一起复杂（）感染疫情的爆发展开了调查。在加利福尼亚州、新泽西州、宾夕法尼亚州、缅因州、内华达州和俄亥俄州发现了 60 例感染病例。这些感染与由制造商 A 生产的一种免冲洗清洁泡沫产品（NRCFP）有关，该产品用于医疗机构中患者的皮肤护理。FDA 检查了制造商 A 的生产设施（生产非处方药品和化妆品的场所），审查了生产记录并收集了产品和环境样本进行分析。FDA 的检查发现了生产过程中的不良操作。脉冲场凝胶电泳分析证实 NRCFP 样本与临床分离株相匹配。制造商 A 进行了大规模召回，FDA 发出警告信，指出制造商的生产操作不规范，并由联邦、州和地方合作伙伴发布了公开信息，建议患者、药店、其他医疗服务提供者和医疗机构停止使用召回的 NRCFP。此次调查强调了遵循适当生产规范以尽量减少化妆品微生物污染的重要性，尤其是如果这些产品拟用于医疗机构。
