Biologics

HCT/P Deviations Seen in OsteoLife Inspection

A 12/6/21-2/4/22 FDA inspection at OsteoLife Biomedical, Miami, FL, documented significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps). A just-released 3/31 Warning Letter says specific items of concern were:

failing to process HCT/Ps in a way that does not cause contamination or cross-contamination during processing and that prevents the introduction, transmission, or spread of communicable disease through the use of the HCT/P;
failing to validate and approve processes according to established procedures where the results of processing cannot be fully verified by subsequent inspection and tests;
failing to monitor environmental conditions where they could reasonably be expected to cause contamination or cross-contamination of HCT/Ps or equipment or accidental exposure of HCT/Ps to communicable disease agents; and
failing to investigate HCT/P deviations and trends of HCT/P deviations relating to core current good tissue practice requirements.

OsteoLife was told to take prompt action to correct the violations addressed in the letter and prevent their recurrence. It was told to respond with a list of specific steps it has taken or will take to correct the violations and prevent them from happening again, with a schedule for completing the corrections. The company also was asked to attend a regulatory meeting to discuss the steps it is taking to correct the violations.

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