FDA Warns Utah Company for Repeated Quality Failures

FDA sent a warning letter, dated May 25, 2017, to Yusef Manufacturing Laboratories, LLC after an inspection of the company’s Clearfield, UT facility found issues regarding batch failure investigations and other quality issues. The inspection was conducted by FDA from May 23–26, 2016. Previous inspections performed by the agency in 2007 and 2011 found similar CGMP deficiencies.

Investigators observed several quality problems, including a lack of a thorough investigation into batch failures and discrepancies. A batch of product failed in-process specification for viscosity. The batch was also discolored. “Firm personnel acknowledged that the batch was, in fact, discolored. You did not investigate the failed test result for viscosity or colorlessness, and released the batch,” FDA stated in the letter.

Adequate written quality procedures were also found to be lacking. The company’s customer complaint hotline had gone unchecked for 15 months and the quality unit failed to ensure that complaints were adequately evaluated.

Written production and process control procedures were also lacking. The company’s manufacturing processes and water system controls were found to be poor. “Your firm had not demonstrated that you can effectively control, maintain, sanitize, and monitor the system so it consistently produces pharmaceutical grade water that, at a minimum, meets the USP monograph for purified water. The water from this unvalidated system is used as a component in your drugs. You lacked testing of the water produced by this system. It is imperative that you routinely test water for chemical (e.g., total organic carbon, conductivity) and microbiological attributes,” the agency stated. The company was asked to provide an action plan to ensure control, maintenance, monitoring, and validation of its water system.

FDA stated in the letter that the company’s June 3, 2016 response to the agency’s findings was inadequate. “While you proposed specific remediations for the violations noted above, the planned remediations are essentially the same as your commitments following previous FDA inspections. These repeated failures demonstrate that your facility’s oversight and control over the manufacture of drugs is inadequate,” the agency stated.

Source: FDA