FDA Cites Yusef Labs for Inadequate Investigations, Quality Concerns

June 9, 2017

The FDA put drugmaker Yusef Manufacturing Laboratories on notice over failures to address batch discrepancies and other quality issues.

The agency issued a warning letter following a May 2016 inspection of Yusef’s facility in Clearfield, Utah, faulting the company for failing to investigate discrepancies including discoloration in some product batches. The firm did not adequately explain how it had investigated and corrected the problem.

The letter also faulted the firm’s quality control unit, which had not checked the customer complaint hotline in over a year. The agency noted similar deficiencies in 2007 and 2011 inspections.

The facility also lacked determinations of conformance for each batch of drug product, and did not test finished products for chemical attributes such as identity and strength. In addition, the facility did not conduct proper testing to validate its water systems.

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