FDA 483 - Kedplasma LLC - March 03, 2026

During an inspection from February 24 to March 3, 2026, Kedplasma LLC in Pharr, TX, was cited for failing to maintain and follow written standard operating procedures for the storage of blood and blood components. Specifically, the firm did not adhere to its "Freezer Map" SOPs, leading to issues with pallet spacing and air flow distribution for source plasma products. These conditions indicate a lack of control over critical storage parameters for biological products.