A manufacturer of several different types of generic over-the-counter drugs, including pediatric medications, is placing consumers at risk to due high levels of bacterial contamination found in its water supply, according to a recent inspection by federal regulators.
The FDA sent a warning letter (PDF) to RIJ Pharmaceutical LLC late last month, which was posted to its website on April 16, indicating the company must redesign and fix its water system due to unacceptably high amounts of bacterial contamination from potentially dangerous organisms.
RIJ Pharmaceutical manufactures generic over-the-counter drugs sold around the world, including antacids, laxatives, cold medications, painkillers and antifungal products in liquid or powdered form. This includes several generic versions of Tylenol products for children.
The FDA letter indicates a March 2019 inspection of RIJ’s facility in Middletown, New York found a failure to meet current good manufacturing practice (CGMP) regulations due to its water system’s problems.
“You have not shown that your water system can consistently product water suitable for drug manufacturing, and at a minimum, meets the USP purified water monograph and appropriate microbial limits,” the warning letter states. “You manufactured oral liquid drugs with water that exceeded microbiological action limits in multiple instances. In addition, upstream points in your water system also had excessive levels of bioburden.”
The FDA noted that water systems with this pattern of problems with high microbial counts indicate a flawed design which allows the formation of biofilm at levels that can overwhelm its purification system.
The agency ordered RIJ to get a comprehensive and independent assessment of its water system, and to provide a plan to “fully remediate design, control, and maintenance of your water system” including detailed blueprints.
The warning letter also notes that the company has failed to establish laboratory controls necessary to ensure its drugs conform to appropriate standards of strength, quality and purity. The letter notes that the company’s microbiological test methods are not adequately verified or validated, highlighting the fact that the system failed to detect B. cepacian, a microorganism, in its system.
The company also failed to test all drugs for impurities, and did not verify its test methods. It also failed to thoroughly investigate unexplained discrepancies following complaints of product odors.
The FDA demanded prompt correction of all of the violations and gave the company 15 working days to respond.