Representing clients in matters of Florida and federal laws and regulations. Licensed to practice law in Florida, only.
On April 3, 2015, the U.S. government filed suit against Wholesome Soy Products of Chicago, to stop the company from distributing food products after an outbreak of Listeria was linked to the company’s mung bean and soybean sprouts, associated with several illnesses last summer. That same day, Wholesome Soy Products Inc. accepted a consent degree outlining conditions it
Read MoreElva Navarro, of Hidalgo,Texas, has been sentenced to three years in federal prison to be immediately followed by one year of supervised release for violating the U.S. Food, Drug and Cosmetics Act by using an adulterated device. Court documents demonstrated that Navarro administered injections of liquid silicone into individuals who would frequent her facility – Bella
Read MoreOn September 16, 2014, Florida’s Agency for Health Care Administration (AHCA) issued a notice to Medicaid providers informing that “in the upcoming weeks the Agency will increase its efforts to ensure that providers are repaying overpayments”, while also reminding Medicaid providers of “their obligation to promptly refund moneys due to [AHCA], including any moneys received
Read MoreHalifax Hospital agreed Monday, March 3, 2014, to settle a whistleblower case for alleged Stark Law violations with the U.S. Justice Department in the amount of $85 million — an amount so large it is more than twice the previous recors for hospital systems accused of Medicare fraud. The Daytona Beach, Florida hospital is accused of
Read MoreOn January 7, 2014, the Federal Trade Commission (FTC) announced a law enforcement initiative to stop deceptive advertising claims to relating to weight- loss products, from food additives and skin cream to dietary supplements. Recognizing that Americans spend billions of dollars every year on supplements, foods and devices in hopes of improving their health and
Read MoreOn December 31, 2013 the U.S. Food and Drug Administration (FDA) issued a warning letter to Star Scientific, Inc. covering two dietary supplement products bearing illegal drug claims and unapproved new dietary ingredients — Antabloc and CigRx The U.S. Food and Drug Administration (FDA) has warned Star Scientific that the therapeutic claims made in association
Read MoreLicensees of the Department of Health are required to renew their licenses biennially in order to maintain the right to practice in the health care industry. The DOH required medical doctors to renew their licenses in two groups: Group 1 – current license will expire at midnight, Eastern Time, January 31, 2014 Group 2 – current license will expire
Read MoreThe U.S. Food and Drug Administration (FDA) issued a warning letter to Jin Han International, Inc., d/b/a Pacific Foods Co., after a facility inspection revealed “serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123)”. According to the letter, the
Read MoreThe FDA has issued Mobile Medical Applications Final Guidance regarding the monitoring of Smartphone software applications with medical applications as a “medical device” under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Consistent with FDA’s existing regulatory approach that considers functionality rather than platform, the FDA intends to exercise its jurisdiction over those mobile
Read MoreDue to the overwhelming positive response after Mrs. Gaitan’s speaking engagement at the FIME International Medical Exposition on “How FDA Regulates Non-Compliant Medical Devices Not Intended for U.S. Consumers”, Mrs. Gaitan will be presenting a webinar on basic FDA requirements for medical devices on Monday, September 30th, 2013. “Introduction to FDA Medical Device Regulatory Requirements”
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