Devices

Multiple Violations at Longhorn Vaccines and Diagnostics

David McFarland

— 2 min read
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A 10/20-10/30/2025 FDA inspection at Longhorn Vaccines and Diagnostics in Bethesda, MD, found multiple violations in the firm’s work as a specification developer of the PrimeStore MTM (molecular transport medium) device intended for the stabilization, transportation, and inactivation of infectious unprocessed nasal washes suspected of containing influenza A virus RNA and unprocessed sputum samples suspected of containing Mycobacterium tuberculosis DNA from human samples. A just-released 2/26 Warning Letter says the specific Quality System Regulation violations were:

  • failure to maintain complaint files and establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit to ensure that all complaints are processed in a uniform and timely manner, that complaints are documented upon receipt, and complaints are evaluated to determine whether the complaint represents an event that is required to be reported;
  • failure to review and evaluate all complaints to determine whether an investigation is necessary and, when no investigation is made, to maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate;
  • failure to investigate any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications, unless such investigation has already been performed for a similar complaint and another investigation is not necessary;
  • failure to establish and maintain procedures for implementing preventive and corrective action, including requirements for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned products, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems using appropriate statistical methodology; investigating the cause of nonconformities relating to product processes and the quality system; identifying the actions needed to correct and prevent recurrence of nonconforming product and other quality problems; and verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device;
  • failure to establish and maintain procedures to control the device design to ensure that specified design requirements are met to demonstrate that the design was developed according to the design control requirements;
  • failure to establish and maintain procedures to control product that does not conform to specified requirements, including the identification, documentation, evaluation, segregation, and disposition of nonconforming product, including a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance, with documentation of the evaluation and any investigation;
  • failure to establish and maintain procedures for rework, including retesting and reevaluation of the nonconforming product after rework to ensure that the product meets its current approved specifications and documentation of rework and reevaluation activities, including determination of any adverse effect from the rework upon the product in the device history record;
  • failure to establish and maintain procedures to ensure that all purchased or otherwise received products and services conform to specified requirements;
  • failure of management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of regulations and the manufacturer’s established quality policy and objectives; and
  • failure to establish procedures for quality audits and to conduct such audits to assure that the quality system complies with the established quality system requirements and to determine the effectiveness of the quality system.

The letter says Longhorn also failed to develop, maintain, and implement written Medical Device Reporting procedures. Its PrimeStore MTM device is adulterated because the company does not have an approved PMA or IDE in effect. It is misbranded because Longhorn did not notify FDA of its intent to introduce the device into commercial distribution.

Longhorn was told to correct the violations promptly and to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with documentation of each step and a schedule for completing the corrections.

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