Tag: Dietary Supplements
Over the years, FDA has issued a number of Import Alerts across various FDA product categories.
Over the years, FDA has issued a number of Import Alerts across various FDA product categories. No issue and no product is off limits. Import Alerts have targeted firms that have not met dietary supplement GMPs, firms that promote unapproved new drugs in the U.S., firms that distribute devices without FDA clearance or approval, and […]
FDA recently published a Warning Letter to dietary supplement manufacturer, Oregon’s Wild Harvest
FDA recently published a Warning Letter to dietary supplement manufacturer, Oregon’s Wild Harvest, reporting a laundry list of violations and issues. While the letter details the many quality control issues that the agency observed during its September 2021 facility inspection, and in spite of the Company’s several attempts to address FDA’s concerns, the agency highlights […]
★★★★★
Working with Shelly on various new product launches over the last couple of years has been seamless. Quick and clear guidance is always what we get.
I've been working with Shelly and her team at Garg law for a little while now and they are fantastic! Very responsive, professional and they certainly get things done. Extremely satisfied with their service and highly recommend.
Ms Garg helped my company navigate an FDA import issue. She achieved an excellent result, was very responsive and professional, and managed to keep the project within budget. She is a stellar attorney.
I have been using Shelly Garg as FDA Counsel for 10+ years, since she was at another international law firm. While we continued to use the previous firm she was at (mainly due to the process required to change firms), we realized the quality of counsel was not the same. We have since been using Garg Law and the ease of use and trust in the knowledge was back instantly. Shelly has the skills to help me understand the regulations (by translating into layman's terms) and risks in a manner that is specific to my business. She is also extremely timely in her responses which is critical when we have a deadline mandated by the FDA. Many other attorneys cite the regulations which l've already read, but need further counsel. In my opinion, this demonstrates Shelly's in-depth knowledge of the regulations, how they pertain to the law, and how they are applicable IRL. Shelly's personable approach and pleasant manner in communication makes it very easy to have been work with her and have productive discussions on the best next steps. She truly has a passion iternational for all things FDA and I've learned so much from her.
