FDA 483 - Donor Services Laboratories Inc Tampa - September 12, 2025

An FDA inspection of Donor Services Laboratories Inc Tampa, a tissue testing facility located in Tampa, Florida, was conducted from September 8 to September 12, 2025. The inspection identified several significant procedural and documentation failures that compromise the integrity of the laboratory"s testing processes. Primary violations included the failure to maintain real-time records; specifically, staff were observed documenting incubation end times before the process was actually completed, meaning records did not reflect actual laboratory activity. Additionally, the firm"s quality program was found to be deficient in investigating and documenting testing failures. Out of 21 failed test runs reviewed, 18 lacked essential details regarding the investigation, outcome, and corrective actions. The laboratory was also unable to produce any records for failed test investigations covering the period from June 2023 to May 2024. Further issues involved incomplete batch records that missed critical information such as the identity of personnel, batch numbers, and specific processing timestamps. These observations were issued under the Federal Food, Drug, and Cosmetic Act to ensure compliance with standards for human cells and tissue-based products. While these findings represent preliminary agency observations, the company is expected to implement corrective actions to address these documentation and quality oversight gaps. The facility must ensure that all laboratory work is recorded accurately as it occurs and that all technical deviations are thoroughly investigated to prevent future occurrences.