Tag Archives: MedWatch

Complaint Handling Under QMSR: Where the FDA Audit Trail Begins

Short answer: Since February 2, 2026, complaint handling under 21 CFR Part 820 is governed by ISO 13485:2016 Clause 8.2.2 together with FDA's supplemental record requirements in § 820.35. Medical Device Reporting under 21 CFR Part 803 did not change: manufacturers must report a death, serious injury, or reportable malfunction within 30 calendar days of

FDA Introduces Streamlined Complaint Process in New Human Foods Program

FDA Update FDA Introduces Streamlined Complaint Process in New Human Foods Program The U.S. Food and Drug Administration (FDA) has recently announced a streamlined process for submitting complaints related to human foods. This new approach aims to improve the agency’s ability to detect and respond to potential problems with FDA-regulated products, including foods and dietary

FDA Update – Warning for Consumers to Avoid Certain Male Enhancement and Weight Loss products Online

The FDA is warning consumers not to use close to 50 male enhancement or weight loss products. These products have been found to contain hidden ingredients and may pose health risks. Products were purchased by the FDA through Amazon and eBay and testing found active pharmaceutical ingredients not included on the label. Some of these

FDA Update: Recommendations About the Use of Dental Amalgam

The FDA has recently been made aware of potential adverse health effects of mercury exposure with the use of dental amalgam to certain groups. This is due to the mercury vapor (gas) released from the dental amalgam fillings. These groups include: Pregnant women and their developing fetuses; Women who are planning to become pregnant; Nursing

FDA Update: FDA Expands Hand Sanitizer Warnings to include 1-propanol Contamination

The FDA is warning consumers about certain hand sanitizer products, including those manufactured by Harmonic Nature S de RL de MI in Mexico, that are labeled to contain ethanol or isopropyl alcohol. After testing, they have proven to be contaminated with 1-propanol contamination. 1-propanol, not to be confused with 2-propanol/isopropanol/isopropyl alcohol, is a toxic and