Pharma & Drug Safety

Draft Guidance: Responding to FDA Form 483 Observations for Drug Manufacturers

The FDA has issued draft guidance for drug manufacturers on how to respond to observations noted on FDA Form 483 following CGMP inspections. This guidance is intended to assist domestic and foreign manufacturers in assessing conformity with CGMP requirements.

Shimadzu FDR Visionary Suite Health Product Recall

Health Canada has issued a Type II recall for Shimadzu Corporation's FDR Visionary Suite medical device due to a potential safety issue with the X-ray high voltage generator. The issue could lead to overheating and smoke. Healthcare providers are advised to contact the manufacturer for more information.

Health product recall: APO-BRIMONIDINE-TIMOP weight out of specification

Health Canada has issued a recall for APO-BRIMONIDINE-TIMOP due to a weight specification issue in lot VK2312. The recall is classified as Type II, indicating a low probability of adverse health consequences. Retailers are instructed to remove the affected product from shelves.

Lifeworks Technology Massage Guns Recalled as Unauthorised Device

Health Canada has recalled Lifeworks Technology Vibra-Heal and Restore Massage Guns because they were distributed without a valid medical device licence. Sales have ceased, and the company plans to apply for the necessary licence.

Olympus MAJ-1443 and MAJ-1444 Valves Recall

Health Canada has issued a Type II recall for Olympus MAJ-1443 and MAJ-1444 valves. These valves are no longer compatible with OER-Pro and OER-Elite automated endoscope reprocessors and require reprocessing via updated instructions. Healthcare providers should contact the manufacturer for further information.

Medline Industries Recalls Catheters Due to Particulates and Infection Risk

The FDA has identified a Medline Industries catheter recall as the most serious type due to potential particulates causing infection or embolism. Affected product lots must be destroyed. This is an expansion of a previous recall.

California Measles Cases Prompt Vaccination Urgency

The California Department of Public Health (CDPH) reported six measles cases in Sacramento and Placer counties, marking the third outbreak in the state this year. CDPH is urging residents to ensure they are fully vaccinated against measles and is working with local health officials to manage potential exposures.

FDA Warning Letter to Premium Health Management

The FDA issued a warning letter to Premium Health Management Inc. for misbranding compounded semaglutide and tirzepatide products. The company's website made false or misleading claims about the products, suggesting they were compounded by Premium Health when they were not, and implying FDA approval or evaluation.

Avian Influenza Detected in Domestic Flock

The Massachusetts Department of Agricultural Resources (MDAR) announced the detection of Highly Pathogenic Avian Influenza (HPAI) in a domestic flock in Dukes County. This marks the second domestic flock in Massachusetts to test positive this year. MDAR is advising poultry owners to implement strong biosecurity measures to prevent exposure.

Potomac River Recreational Water Advisory Partially Lifted

The Virginia Department of Health (VDH) has partially lifted a recreational water advisory for the Potomac River, effective March 5, 2026. The advisory remains in place north of Chain Bridge due to elevated E. coli levels following a sewage spill.