Longhorn Vaccines and Diagnostics LLC

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Failure to review and evaluate all complaints to determine whether an investigation is necessary. When no investigation is made, the manufacturer shall maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate, as required by 21 CFR 820.198(b).

Passage 2

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, as required by 21 CFR 820.198(c).

Passage 3

Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met to demonstrate that the design was developed in accordance with the design control requirements, as required by 21 CFR 820.30(a) through 820.30(j).

Passage 4

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. The evaluation of nonconformance shall include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance. The evaluation and any investigation shall be documented, as required by 21 CFR 820.90(a).

Passage 5

Failure to establish and maintain procedures for rework, to include 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 (DHR), as required by 21 CFR 820.90(b)(2).

Passage 6

Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50.

Passage 7

Your firm did not have records of acceptable suppliers (“Longhorn Supplier List” dated 10/28/25), until during this inspection, as required by 21 CFR 820.50(a)(3).

Passage 8

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 this part and the manufacturer's established quality policy and objectives, as required by 21 CFR 820.20(c).

Passage 9

Failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22.

Passage 10

Failure to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17.