FDA Roundup: A Look at the Latest FDA Activity
While the year is winding down, FDA remains active in enforcement and issuing new guidance. Here’s a look at what has been happening at the Agency.
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Category: OTC Drugs
FDA Flexes Enforcement Muscle
In Multi-Company Warning Letters Issued to Dietary Supplement Companies. FDA Issues Seven Warning Letters to Dietary Supplements Claiming to Treat Cardiovascular Disease.
Checking it twice: FDA Facility Registration Renewals!
A reminder to register or renew your food, dietary supplement, OTC drug, or medical device facility registration before December 31, 2022
FDA Welcomes 2022/2023 VQIP Participants
Revisiting the Perks of FDA’s Voluntary Qualified Importer Program (VQIP)
FDA welcomed 2022/2023 Voluntary Qualified Importer Program (VQIP) Participants, as the benefit year begins October 1, 2022. FDA’s VQIP provides a unique badge of honor for importers, signifying that importers have obtained a high level of safety and security over their supply chains. While bearing conceptual similarities to CBP’s trusted trader programs, we also like […]
One, Two, Three Strikes, and you’re…on an FDA Import Alert!
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 […]
Family Dollar Announces Voluntary Recall
Family Dollar Announces Voluntary Recall of OTC Products Stored Outside of Temperature Requirements
Family Dollar initiated a voluntary retail level product recall of FDA regulated products that were stored and shipped to certain stores between May 1, 022 – June 10, 2022 outside of labeled temperature requirements. A complete list of OTC medical devices covered by the recall is provided here , and the earlier July 21, 2022 […]
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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.