Drugs

Repeat CGMP Deviations at Fresenius Unit

David McFarland

— 2 min read
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A 9/12/22-9/24/22 FDA inspection at the Fresenius Kabi Fenwal International unit in Maricao, PR, found significant deviations from current good manufacturing practice (CGMP) requirements in the manufacture of the firm’s blood pack units with and without in-line leukoreduction filters, Alyx component solutions, Amicus component solutions, and InterSol platelet additive solution. A just-released 9/14 Warning Letter says that after providing the company with a form FDA-483 listing significant deviations, the agency identified additional significant deviations on further review of the information collected during the inspection. The letter says specific deviations were:

  • failing to follow established, written procedures and thoroughly investigate any unexplained discrepancy of the failure of a batch or any of its components to meet its specifications, whether or not the batch had already been distributed;
  • failing to test in-process materials for identity, strength, quality, and purity, as appropriate, and approve or reject by the quality control unit during the production process;
  • failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including procedures for validation of all aseptic and sterilization processes;
  • failing to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements;
  • failing to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair; and
  • failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, and test procedures designed to assure that components, in-process material, and drug products conform to appropriate standards of identity, strength, quality, and purity.

FDA says some of the firm’s corrective actions in response to the form FDA-483 did not provide sufficient detail to assess their adequacy.

“Your firm, including your quality unit, continuously has failed to adequately correct your violations and, for those violations that FDA has observed during previous inspections, prevent their recurrence,” FDA says. “Indeed, the nature of your violations demonstrates that your quality control unit has failed to ensure that your firm manufactures drug products that meet established specifications for identity, strength, quality, and purity.”

The letter says the firm’s CGMP deviations pose a significant risk that its products may be contaminated with microorganisms.

Fresenius was told to respond with a list of specific steps it has taken or plans to take to address violations and prevent their recurrence, with documentation necessary to show that the matters have been addressed and a timetable for completing the corrections.

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