Hemarus LLC — FDA Warning Letter Findings

Failure of the responsible physician to approve reinstatement of the donor into the plasmapheresis program when the donor’s protein composition values have returned to an acceptable level [21 CFR 640.65(b)(2)(i)]. For example, a serum protein electrophoresis test for a sample collected on March 22, 2024, from donor (b)(6) showed results with a total protein less than 6.0 grams per deciliter. Another sample collected from the donor on April 2, 2024, was within normal limits, and was reviewed and approved by physician substitute AP on April 8, 2024. However, there is no documentation that the responsible physician approved the reinstatement of this donor into the plasmapheresis program as required. Source Plasma was subsequently collected from donor (b)(6) on April 26, 2024.

Failure of the personnel responsible for the collection, processing, compatibility testing, storage or distribution of blood or blood components to have adequate training and experience, including professional training as necessary, or combination thereof, to assure competent performance of their assigned functions, and to ensure that the final product has the safety, purity, potency, identity and effectiveness it purports or is represented to possess [21 CFR 606.20(b)]. For example, since September 27, 2022, nine of (b)(4) employees approved as physician substitutes by your Medical Director failed to complete the (b)(4) (minimum) training program required by your Standard Operating Procedure, 03.05, “Physician Substitute Training Program”(Effective Date: 05-27-20).

Failure to maintain records concurrently with the performance of each significant step in the collection, processing, compatibility testing, storage and distribution of each unit of blood and blood components so that all steps can be clearly traced. All records shall be legible and indelible, and shall identify the person performing the work, include dates of the various entries, show test results as well as the interpretation of the results, show the expiration date…

Failure to follow written standard operating procedures for all steps in the collection, processing, storage, and distribution of blood and blood components for further manufacturing purposes [21 CFR 606.100(b)]. For example, on April 15, 2024, FDA investigators observed freshly collected units of Source Plasma being placed immediately inside cardboard boxes in freezer (b)(4) . This deviated from your Standard Operating Procedure, 06.15, “Plasma Product Storage” (Effective…