Regulatory Guidance

FDA warns drugmaker after bacteria found in facility water

Apr 17, 2019

The FDA has issued a warning letter to RIJ Pharmaceutical following an inspection that uncovered unacceptable levels of three bacteria in water used in operations. 

According to the letter, the agency found multiple process and quality control deficiencies, such as poor water control, at the company’s Middleton, New York facility where the RIJ produces over-the-counter products, including medicines for children. 

“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 agency stated.

The agency said that the company also failed to conduct process validation studies for its mixing operations, which caused variabilities in drug concentrations and super-potent batches that needed to be reworked. 

RIJ reportedly failed to test drugs for impurities or adequately validate its testing methods. 

The FDA has now demanded that the company conduct an independent evaluation of its change management system, investigate inaccuracies in data records, conduct a risk assessment on its product quality, and provide evidence that it is working to review various procedures at the plant.  

Read the warning letter.