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IMPORTERS, ARE YOU READY? THE DUE DATE IS AROUND THE CORNER

The FDA Foreign Supplier Verification Program (FSVP) due date is almost here for those importers who did not fall under a previous deadline.  FDA has determined that March 18, 2018 is the deadline for companies with less than 500 full time equivalent employees. The prior deadline for companies with over 500 full time equivalent employees […]

Are You Meeting DSHEA Requirements for Dietary Supplements?

Manufacturers of dietary supplements have a heavy burden to ensure the safety and efficacy of products they produce. There are strict regulations to adhere to as outlined in the Dietary Supplement and Health Education Act (DSHEA). Is your facility meeting these requirements? Find out now and how to get help becoming certain that your supplements are meeting […]

How to Maintain Compliance When Manufacturing Cosmetics

While cosmetics are one of the least regulated group of products by the Food and Drug Administration (FDA), there are still some guidelines that need to be followed. This is particularly true if you’re a small business making cosmetics at home, a salon, or small facility and aren’t manufacturing on a large scale. Here’s how […]

The Florida Bar Leadership Academy Committee 2020

Capote Law Firm is proud to announce that attorney Lisa Capote has been appointed to the Florida Bar Leadership planning committee. Mrs. Capote is a Leadership Academy Class 3 alumni, having participated in the program during 2015 – 2016.  The Wm. Reece Smith, Jr. Leadership Academy is a multi-session training program designed to assist a […]

Why Classify Your Medical Device for the FDA?

Classifying your medical device with the FDA can seem overwhelming. It’s important to take things one step at a time. There are three major classifications for medical devices under FDA law. It’s crucial to understand why you need to classify your medical device. What Requirements Should You Be Meeting While Designing or Manufacturing Your Device? Learning […]

Is Your Product Label Up to Code?

The FDA strictly regulates what you put on your product label if you’re manufacturing or selling dietary supplements. Recently, a popular essential oil and aromatherapy company came under FDA fire for claims of treating and curing diseases. This is a clear violation of the Federal Food, Drug, and Cosmetic Act (FDCA). Here’s what you need […]

Does Your Cosmetic Contain Prohibited Ingredients?

If you’re working to get your cosmetic on shelves, the process can seem challenging and at times, even frustrating. One way to increase your chances of success is to ensure your cosmetic does not contain ingredients prohibited by the FDA. Here’s what you should know. Cosmetics Are Not “Approved” by the FDA, and the Spirit […]

Blue Buffalo recalling some dog food

  NASHVILLE, Tenn. (WFLA) – A dog food product sold nationwide is being recalled due to a potential health risk. Blue Buffalo Company voluntarily recalled some of its BLUE Wilderness Rocky Mountain Recipe Red Meat Dinner Wet Food for Adult Dogs. The company says the product could have elevated levels of beef thyroid hormones. Ingesting […]

How to Classify Your Medical Device for the FDA

When you have a medical device to register with the FDA, the first step is to classify the device. The device’s classification will help identify the it within the FDA and determine the device’s level of risk. By understanding how to classify your medical device, you can ensure your device is properly registered and ready to market. […]

Egyptian strawberries and Hepatitis A

Federal officials reported an ongoing investigation into a Hepatitis A outbreak linked to frozen Egyptian strawberries served in smoothies.  There 134 people were reportedly ill. 70% of the individuals reportedly ill have required hospitalization. Almost all individuals interviewed reported drinking smoothies containing strawberries. Food and Drug Administration investigators have been using the working theory that […]

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