Biologics

FDA Finds HCT/P Deviations at Utah Cord Bank

A 2/1-2/11 FDA inspection at Utah Cord Bank, Sandy, UT, documented significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps). A 5/11 Warning Letter says specific deviations were:

failing to validate and approve a process according to established procedures where the results of processing cannot be fully verified by subsequent inspection and tests, including documentation of the validation activities and results with the date and signature of the person approving the validation;
failing to adequately monitor environmental conditions and provide proper conditions for operations, where environmental conditions could reasonably be expected to cause contamination or cross-contamination of HCT/Ps or equipment, or accidental exposure of HCTPs to communicable disease agents;
failing to establish and maintain procedures appropriate to meet core current good tissue practice requirements for all steps that the cord bank performs in the manufacture of HCT/Ps; and
failing to maintain records concurrently with the performance of each step required in regulations.

The letter acknowledges that the firm has retained a consultant but says its response was silent regarding specific corrective actions to address the violations.

Utah Cord Bank was told to respond with a list of specific steps it has taken or plans to take to correct the violations and prevent their recurrence, with the documentation necessary to show that the correction has been achieved, and a timetable for completing the work.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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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