Pharma & Drug Safety

FDA Warning Letter to Beta Bionics, Inc.

The FDA issued a warning letter to Beta Bionics, Inc. regarding violations of the Quality System Regulation for their iLet Dosing Decision Software and iLet ACE Pump. The letter details failures in corrective and preventive action procedures, including inadequate analysis of complaints leading to serious adverse health outcomes.

Potomac River Recreational Water Advisory Update

The Alexandria Health Department (AHD) has provided an update on the recreational water advisory for the Potomac River, originally issued by the Virginia Department of Health. The advisory continues, recommending avoidance of water activities in the river, with no end date specified. Testing for bacteria is underway, with results pending.

Rabies Alert in Hopewell City, VA

The Virginia Department of Health issued a rabies alert for Hopewell City, VA, following confirmation of a stray cat testing positive for the virus. Residents are urged to ensure pet vaccinations are current and to report any stray animals or potential exposures.

Colorectal Cancer Screening Guidance

The Virginia Department of Health has issued guidance recommending that individuals at average risk for colorectal cancer begin screening at age 45. The guidance highlights rising rates in younger adults and emphasizes the importance of early detection through screening tests.

IDPH Releases Carbon Monoxide Surveillance Report

The Illinois Department of Public Health (IDPH) has released its first carbon monoxide surveillance report, detailing unintentional CO exposures from 2019-2023. The report aims to strengthen prevention and awareness efforts to reduce emergency room visits, hospitalizations, and deaths related to CO exposure in Illinois.

FDA Import Alert: GLP-1 Receptor Agonist Bulk Drug Substances

The FDA has issued Import Alert #66-80, placing Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist Bulk Drug Substances on Detention Without Physical Examination. This action is due to concerns that these substances, used in compounding, may be adulterated and not meet current good manufacturing practice (CGMP) requirements.

FDA Import Alert 16-120: Detention of Non-Compliant Fish Products

The FDA has updated Import Alert 16-120, revising guidance for field personnel regarding the detention without physical examination (DWPE) of fish and fishery products from foreign processors not in compliance with the Seafood HACCP regulation. The update includes changes to the title, reason for alert, and guidance sections, incorporating foreign remote regulatory assessments as a compliance verification method.

FDA Import Alert 98-06: New Tobacco Products Detained Without Authorization

The FDA has updated Import Alert 98-06, which detains new tobacco products lacking required marketing authorization. This revision clarifies guidance and agency contacts, noting that ENDS products are now covered under a separate alert (98-07). Manufacturers and importers must ensure proper authorization to avoid detention.

Savannah Bee Company Recalls BBQ Sauce Due to Undeclared Allergens

Savannah Bee Company is recalling its Honey BBQ Sauce-Mustard due to undeclared wheat and soy allergens. The recall was initiated after a customer reported mislabeled products containing the 'Honey BBQ Sauce-Sweet' ingredients. Consumers are urged to dispose of the product and seek a refund.

Measles Case Confirmed in Broomfield, CO

Colorado public health officials have confirmed a measles case in Broomfield County and identified several public locations with potential exposure. The case is not linked to previous exposures, suggesting potential unidentified community transmission. Residents are advised to monitor for symptoms and seek medical attention if exposed.