Utah OTC Firm Warned for Oversight and Sterility Problems
The FDA hit OTC drugmaker Results RNA with a second warning letter in just over a year, this time for GMP violations at its Orem, Utah facility.
The agency issued the first warning letter in April 2018 for misbranded drugs. A reinspection from Dec. 3-18, 2018 found the quality unit lacked adequate oversight of the firm’s sterile products.
Following the agency’s visit, the drugmaker in January voluntarily recalled its Lubrisine eye drops because of manufacturing problems that led to the presence of colloidal silver used in separate products.