FDA warns Globus subsidiary HBT over ViaCell production facility issues

The FDA this week released a warning letter it sent to a Globus Medical (NYSE:GMED) subsidiary Human Biologics of Texas, which produces the company’s ViaCell allograft product, over issues it found during an inspection of the facility in April. The federal watchdog noted multiple infractions during the initial inspection, and also provided a response to corrective actions the company said it was taking in response to the earlier noted issues. In its in inspection, FDA investigators noted failures to document and investigate deviations in its production of the ViaCell product as well as trends of deviations away from the agency’s core current good tissue practice requirements. “For example, since the start of ViaCell processing in October 2016 through August 2017, you have had monthly sterility failure rates of [redacted] during seven of those months, with one month having a sterility failure rate of [redacted]. Your firm failed to conduct an investigation of all these sterility failures to determine the cause. You also failed to investigate additional sterility failures that occurred from October 2017 through February 2018. By neglecting to identify the cause of the sterility failures, you also failed to take appropriate corrective action(s) to prevent recurrence of the failures,” the FDA wrote in its letter. The agency also noted a failure to “validate and approve a process according to established procedures where the results of processing...
Source: Mass Device - Category: Medical Devices Authors: Tags: Food & Drug Administration (FDA) Regenerative Medicine Regulatory/Compliance Globus Medical Source Type: news

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There have been significant advances in the care of burns over the past decade. As a result of the improved survival of burn patients, attention has shifted to the optimized management of their wounds. Traditionally, autografts have been described as the g...
Source: SafetyLit - Category: International Medicine & Public Health Tags: Burns, Electricity, Explosions, Fire, Scalds Source Type: news
Authors: Marecek G, Centomo H Abstract Despite advances in technology such as locked plating, osteoporotic bone and bone defects remain challenging complications for orthopaedic surgeons. The concept of augmented fixation is useful in these settings. Augmented fixation can be described as improving construct strength and stability by enhancing the surrounding environment. By understanding and using the techniques of alternative fixation strategies, endosteal or medullary support, structural grafting, or the use of bone graft substitutes in combination with standard or integrated fixation, surgeons can improve the c...
Source: The Journal of the American Academy of Orthopaedic Surgeons - Category: Orthopaedics Tags: J Am Acad Orthop Surg Source Type: research
In this study, we have developed a nanocomposite fibrous scaffold [silica coated nanoHA-gelatin reinforced with electrospun poly(L-lactic acid) (PLLA) nanoyarns] and evaluated its efficacy to promote osseointegration in rabbit mandibular defect in comparison to the scaffold without fibers and commercial nanoHA-collagen graft. For this, critical sized bilateral defect (10 mm length, 3 mm depth and 3 mm width) was created in rabbit mandible and dental implantation was done in two manners. In strategy 1, Ti dental implant was placed along with the scaffold and in strategy 2, the scaffold was implanted for 3 months to ...
Source: Materials Science and Engineering: C - Category: Materials Science Source Type: research
ConclusionsLimited diagnostic capabilities and lack of access to eculizumab prevent the implementation of international guidelines for HUS in most developing countries. We propose practice guidelines for India, which will perhaps be applicable to other developing countries.
Source: Pediatric Nephrology - Category: Urology & Nephrology Source Type: research
This study aimed to investigate the effects of recombinant human bone morphogenetic protein (rhBMP-7) on human cancellous bone grafts (BGs) while differentiating between anabolic and catabolic events. Human BGs alone or supplemented with rhBMP-7 were harvested 14  weeks after subcutaneous implantation into NOD/Scid mice, and studied via micro-CT, histomorphometry, immunohistochemistry and flow cytometry. Immunohistochemical staining for human-specific proteins made it possible to differentiate between grafted human bone and newly formed murine bone. Only BG s implanted with rhBMP-7 formed an ossicle containing a funct...
Source: Calcified Tissue International - Category: Orthopaedics Source Type: research
Chronic Achilles tendon ruptures typically are treated with surgical intervention except in low-demand patients or patients who are unable to tolerate surgery. Although several treatment strategies are described, most literature is case reports and case series. There is no widely accepted algorithm or gold standard for surgical treatment of chronic Achilles tendon ruptures. Treatment strategy depends on the size of the tendon gap after excision of nonviable tissue and scar tissue. Smaller gaps can be treated with direct end-to-end repair. Medium-sized gaps can be treated with tendon-lengthening procedures. Tendon transfers...
Source: Foot and Ankle Clinics - Category: Orthopaedics Authors: Source Type: research
AbstractThe use of musculoskeletal allografts has become increasingly popular among surgeons. The purpose of this review  is to highlight the procurment and delievery process of fresh osteochondral allografts in the United States. The four distributors of fresh osteochondral allografts in the United States were contacted. Surveys containing quantitative and qualitative sections concerning the procurement and process ing of osteochondral allograft tissue were obtained. Our results showed an average of 13 ± 4.24 years of experience with osteochondral allografts. The average donor age range...
Source: Cell and Tissue Banking - Category: Stem Cells Source Type: research
RNA-seq is poised to play a major role in the management of kidney transplant patients. Rigorous definition of housekeeping genes (HKG) is essential for further progress in this field. Using single genes or a ...
Source: BMC Medical Genomics - Category: Genetics & Stem Cells Authors: Tags: Research article Source Type: research
We describe a case of a 43-year-old CMV-seronegative patient who underwent kidney transplantation from a CMV-seropositive donor and developed CMV disease despite valganciclovir prophylaxis. CMV viral load increased even though valgangiclovir dose was augmented and immunosuppressive therapy reduced. CMV genotyping revealed mutations in the viral UL97 protein kinase, explaining ganciclovir-resistant CMV infection. The viral load failed to respond to foscavir, cidofovir and CMV-neutralizing immunoglobulins. Kidney allograft dysfunction developed 3 months post-transplantation with a histopathologic diagnosis of CMV neph...
Source: Antiviral Therapy - Category: Virology Source Type: research
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Source: Hip International - Category: Orthopaedics Authors: Tags: Hip Int Source Type: research
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