Pharma & Life Sciences

FDA Warning Letter to Dynamic Stem Cell Therapy

The FDA issued a warning letter to Dynamic Stem Cell Therapy for misbranding an umbilical cord-derived stem cell product. The product is considered an unapproved new drug and an unlicensed biological product, violating the Federal Food, Drug, and Cosmetic Act. The FDA's review found claims on the company's website indicating the product is intended to diagnose, cure, mitigate, treat, or prevent disease.

FDA Warning Letter to AQ USA Inc. for Drug Manufacturing Violations

The FDA issued a warning letter to AQ USA Inc., d.b.a Ross Healthcare Inc., for significant Current Good Manufacturing Practice (CGMP) violations at its drug manufacturing facility in Lynden, Washington. The violations include inadequate laboratory testing for microbial contamination and failure to establish appropriate specifications for drug products.

FDA Warning Letter to A. Nelson & Co. Ltd

The FDA issued a warning letter to A. Nelson & Co. Ltd. for significant violations of Current Good Manufacturing Practice (CGMP) regulations, including inadequate microbial testing and unsupported expiration date extensions. The company's drug products were found to be adulterated.

HHS OIG: Sarasota Memorial Hospital Medicare Overpayments Total $12.1 Million

The HHS Office of Inspector General (OIG) found that Sarasota Memorial Hospital received at least $12.1 million in Medicare overpayments between January 1, 2020, and December 31, 2021. The OIG recommended the hospital refund the overpaid amount and implement additional training.

HHS OIG Report: Alaska Missed Foster Care Opportunities for Native Children

The HHS Office of Inspector General issued a report finding that Alaska missed opportunities to protect American Indian and Alaska Native children missing from foster care. The report details failures in notification, follow-up actions, sex trafficking assessments, caseworker visits, and tribal communication, recommending improvements supported by ACF.

Trividia Health Corrects True Metrix Blood Glucose Meters Due to Injuries and Death

The FDA issued an Early Alert regarding Trividia Health's correction of TRUE METRIX, TRUE METRIX AIR, TRUE METRIX GO, and TRUE METRIX PRO Blood Glucose Monitoring Systems due to reports of injuries and death. The correction updates instructions for the E-5 error code, which indicates very high blood glucose results or test strip errors.

Olympus Insufflation Units Recalled by FDA Due to Software Issues

The FDA has classified a recall of Olympus High Flow Insufflation Units (models UHI, UHI-2, UHI-3) as Class I due to a software issue that could lead to overpressure events, potentially causing serious injury or death. Olympus is removing these discontinued devices from the market, and users are instructed to immediately cease usage and quarantine affected units.

FDA Early Alert: Abiomed Heart Pump Purge Cassette Issue

The FDA issued an Early Alert regarding a potentially high-risk issue with Abiomed's Impella Purge Cassettes and Pump Sets. The issue involves an increased risk of purge leaks in Generation 1 Purge Cassettes, which could lead to pump stops and patient death. Abiomed has recalled affected products, and four serious injuries have been reported.

Boston Scientific Recalls AXIOS Stents Due to Deployment Issues

The FDA is alerting the public about a recall of Boston Scientific AXIOS Stents and Electrocautery Enhanced Delivery Systems due to issues with stent deployment. The recall has been identified as the most serious type, with 167 injuries and 3 deaths reported. Healthcare providers are instructed to immediately stop distribution or use of affected devices.

Go Raw LLC Recalls Cat Food Due to Low Thiamine

Go Raw LLC is voluntarily recalling one lot of Quest Cat Food Chicken Recipe Freeze Dried Nuggets due to low thiamine levels. The recall was initiated after one report of illness in a cat, which has since recovered. Consumers are advised to stop feeding the product and return it for a refund.