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FDA sent a warning letter to Bicooya Cosmetics Limited after inspectors found rodent feces at the company’s Zhejiang, China facility.
FDA sent a warning letter, dated August 11, 2017, to Bicooya Cosmetics Limited after inspectors found violations of current good manufacturing practices (CGMPs) at the company’s Shangxi Town, Zhejiang, China facility. Violations found during the inspection, which was conducted May 22–25, 2017, included the presence of rodent feces throughout the facility.
In the letter, FDA stated that inspectors observed rodent feces in proximity to filling machines, raw materials, and finished drug products. The agency also stated that the company failed to properly clean, sterilize, and maintain equipment and utensils.
The company also failed to properly test batches of drug product, nor did they properly record batch and/or control records. “In addition, analytical testing records were missing data, dates, and signatures. Our investigator observed your staff altering information in analytical test reports during the inspection. For example, you significantly altered the analytical testing report for (b)(4) Ointment lot (b)(4), although this lot had already been distributed to the US market,” FDA stated.
FDA placed the company on Import Alert 66-40 on June 29, 2017. The agency recommended the company hire a CGMP consultant and perform data integrity remediation.