Biologics

Deviations from HCT/P Regs Found at R&B Medical

A 9/16-9/25/19 FDA inspection at R&B Medical Group, Van Nuys, CA, found significant deviations from regulations for human cells, tissues, and cellular and tissue-based products (HCT/P) in the company’s work as a testing laboratory that performs communicable disease testing under contract for fertility clinics and medical practices. A 1/15 Warning Letter says the specific deviations were:

failing to test using appropriate FDA-licensed, approved, or cleared donor screening tests in accordance with the manufacturer’s instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases;
failing to establish and maintain procedures for all steps performed in testing, screening, and determining donor eligibility, and complying with all other cited regulatory requirements;
failing to establish and maintain procedures for the review, evaluation, and documentation of complaints relating to core current good tissue practice requirements and the investigation of complaints as appropriate;
failing to establish and maintain a quality program that includes investigating and documenting HCT/P deviations relating to core HCT/P deviations and trends of HCT/P deviations relating to core current good tissue practice requirements; and
failing to maintain records concurrently with the performance of each step required in regulations.

The letter also says the agency “is very concerned with your policy of representing the results of screening tests for relevant communicable diseases as negative after performing confirmatory or additional testing.” R&B was told to perform a retrospective review of results of all screening tests for relevant communicable diseases and identify those that were repeatedly reactive but were incorrectly reported to the firm’s clients as negative based on the results of confirmatory testing, Nucleic Acid Testing, or Immunoblot testing. The company was told that once it identifies test results that were not accurately reported to clients, it should notify the clients of the correct result for relevant communicable diseases.

R&B also was told to take prompt action to correct the violations and to respond with a list of specific actions taken or planned to correct the violations and prevent their recurrence, with documentation for each action, and a timetable for completion.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome