The year 2020 started out ordinarily enough for the FDA Compliance Simplified team. We had projects related to foods, dietary supplements, over the counter drugs (OTC), pet foods, and medical devices. On March 2nd we received our first call regarding a project related to the new virus that was beginning to affect the United States.
FDA has issued new policies affecting the food, dietary supplement, drug, and medical device industries in response to the COVID-19 pandemic.
Last month I attended Supply Side West where my company, in conjunction with Nosco, Inc, presented information on packaging, labeling, and compliance. I spoke to a small group of attendees about how labels function as the table of contents to information about your product; information that [...]
FDA warning letters continue to provide information that give insight into the level of detail of FDA inspection, which are relatively new to the dietary supplement industry and may help your company avoid problems when your inspection comes up. In a February 9, 2011 letter [...]
Hello! I hope this brief update finds you well. Here in the US Summer’s heat is unrelenting and FDA is turning up the heat also. I learned today that FDA has issued letters to foreign food facilities that they will be inspected between October 1, [...]
Hello! Trade newsletters are reporting that FDA Commissioner, Dr. Margaret Hamburg’s remarks at the Food and Drug Law Institute conference discussed her priority to respond to the increase in adulterated and misbranded imported food products. Many of our clients have noted the increased scrutiny of [...]
In an informal conversation with a current FDA staff member I learned that the agency is expecting to issue many more warning letters and to follow up on those warnings much more quickly. Why is this? First, last fall the agency hired hundreds of new [...]