Drugs

Adulterated Drugs at SCA Outsourcing Facility: FDA

David McFarland

— 1 min read
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A 10/20-10/30/2025 FDA inspection at SCA Pharmaceuticals’ outsourcing facility in Little Rock, AR, found serious deficiencies in the firm’s practices for producing drug products that are intended or expected to be sterile. A just-released 9/14 Warning Letter says the agency investigator collected evidence indicating the drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions through which they may have become contaminated with filth or rendered injurious to health, causing the drug products to be adulterated under the Federal Food, Drug, and Cosmetic Act.

The letter also lists these current good manufacturing practice (CGMP) regulation violations:

  • failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes;
  • failure to establish an adequate air supply filtered through high-efficiency particulate air filters under positive pressure in the aseptic processing areas;
  • failure 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 had already been distributed; and
  • failure 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.

FDA says that some of the firm’s proposed corrective actions in its responses to a Form FDA-483 appear to be adequate, while the adequacy of other proposed actions can’t be determined due to a lack of supporting documentation.

SCA was told to take prompt action to address the violations and to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with copies of related documentation and a schedule for completing the corrections.

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