Rodent faeces and damaged equipment land Chinese OTC maker FDA warning
An inspection at the facility in Yiwu Zhejiang, China in May found significant violations of current good manufacturing practice (cGMP), resulting in the US Food and Drug Administration (FDA) issuing the over-the-counter (OTC) medicine maker with a warning letter earlier this month.
“Your firm failed to keep the buildings used in the manufacture, processing, packing, or holding of a drug product free of infestation by rodents, birds, insects, and other vermin,” the FDA said in the letter, published yesterday.
Specifically the investigator “observed rodent feces” throughout Bicooya’s facility, including in direct proximity to the filling machine where OTC drug products are made, and around both raw materials and finished drug products in the warehouse.
The FDA also hit out at the firm’s failure to clean, maintain and sanitise equipment at the site.
“For example, our investigator observed residue build-up in the (b)(4) tanks you use to manufacture OTC drug products, and damaged transfer hoses held together with plastic wrap. When an employee attempted to open a (b)(4) tank lid during the inspection, a hinge broke.”
Other violations cited in the letter included failing to conduct microbial testing for each batch of drug product released meaning there was insufficient assurance that the products distributed were safe and sanitary, and issues with data integrity.
“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.”
US imported products from the site have been banned since June 29, and the FDA has asked Bicooya to provide a comprehensive investigation into the extent of the inaccuracies in data records and reporting, a risk assessment report and a corrective and preventive action plan.
