New York Facility Receives Warning Letter

RIJ Pharmaceutical LLC received a warning letter, dated March 28, 2019, after an inspection of the company’s Middletown, NY facility found a variety of process and quality control deficiencies.  The inspection occurred from April 3–13, 2018.

Specifically, the company’s water system was not properly designed, according to FDA. “You have not shown that your water system can consistently produce water suitable for drug manufacturing, and, at a minimum, meets the USP purified water monograph and appropriate microbial limits. 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 … It is essential that you design your water system to ensure consistently high purity water that is suitable for its intended use. High bioburden or objectionable microbes in the water used as an ingredient in your drugs may pose significant risk to consumers,” the agency stated.

FDA requested the company provide a comprehensive, independent assessment of its water system; a corrective actions and preventative actions plan to remediate its water system; a validation report of the water system after improvements are implemented; and total count limits for each stage of the system.

According to the letter, the company also failed to thoroughly investigate batch failures, establish adequate written quality procedures, and ensure complete laboratory data records. “Significant findings in this letter indicate that your quality unit is not able to fully exercise its authority and/or responsibilities. You must provide the quality unit with appropriate authority, sufficient resources, and staff to carry out its responsibilities to consistently ensure drug quality,” the agency stated.

FDA recommended the company hire an independent consultant to help it comply with current good manufacturing practices.

Source: FDA