Hemarus 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 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)].

Passage 2

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)].

Passage 3

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)].

Passage 4

Failure to make and record a thorough investigation, including the conclusions and follow-up, of any unexplained discrepancy or the failure of a lot or unit to meet any of its specifications [21 CFR 606.100(c)].

Passage 5

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 assigned to specific products, and be as detailed as necessary to provide a complete history of the work performed [21 CFR606.160(a)(1)].