Drugs

FDA Finds Repeat Violations at Yusef Labs

David McFarland

— 1 min read
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A 9/20-9/24/21 FDA inspection at Yusef Manufacturing Laboratories, Clearfield, UT, found significant repeated violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 2/8 Warning Letter lists specific violations as: 

  •          failing to conduct at least one test to verify the identity of each component of a drug product and failing to validate and establish the reliability of the component supplier’s test analyses at appropriate intervals;
  •          failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
  •          failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity;
  •          failing to establish written procedures for production and process control designed to assure that the drug products manufactured have the identity, strength, quality, and purity they purport or are represented to possess; and
  •          failing to follow an adequate written testing program designed to assess the stability characteristics of drug products and to use stability testing results to determine appropriate storage conditions and expiration dates.

The letter says FDA cited Yusef for similar violations in a 2017 Warning Letter, a 2020 regulatory meeting, and inspections in 2007, 2011, 2016, 2018, and 2019. “You had committed to remediating the cited violations and observations in your response,” the agency said. “Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.”

FDA strongly recommends the firm retain a qualified consultant to assist it in meeting CGMP requirements.

Yusef was told to correct violations promptly and to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with a schedule for completing the corrective actions.

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