An Early FDA Holiday Present!
FDA (FINALLY) Announces Opening of Cosmetics Direct Portal for Electronic Registration and Listing of Cosmetic Product Facilities and Products
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Tag: Enforcement
FDA Revisiting Classification of Wound Dressings and Liquid Wound Washes
Last week, FDA proposed two new rules to classify certain unclassified, wound dressings and liquid wound washes containing antimicrobials or other chemicals into three separate classification regulations: Solid wound dressings: this covers products intended to cover and protect a wound against external contamination, to absorb exudate and to maintain appropriate moisture balance within the wound […]
A Sprinkle of Holiday (Lead-Free) Cinnamon Spice?
FDA Screens Incoming Shipments of Cinnamon for Lead Contamination as a Result of Recalled Apple Cinnamon Fruit Pouches.
Enforcement Delayed by 6 Months
Update on FDA Cosmetic Product Facility Registration and Cosmetic Product Listing Requirements
FDA Releases Updated Draft Guidance
On the Preventive Controls for Human Food Rule, Food Allergen Program and Acidified Foods
Avoid Blushing and Don’t Let GMP Violations Add to Your Highlight
Prepping for a MoCRA and FDA Cosmetics Inspection In a recent News & Insights publication, we addressed FDA’s significant inspection increase, including top citations for each product category, and what to expect and how to prepare for an FDA routine surveillance inspection. With the implementation of the Modernization of Cosmetics Regulations Act of 2022 (MoCRA) […]
FDA Inspections on the Rise
What to Expect and How to Prepare FDA’s renewed focus on foreign and domestic inspections via onsite routine surveillance inspections, unannounced inspections and remote regulatory assessments continues to climb across all FDA-regulated industries. Following a pandemic pause, foreign inspections are particularly on the rise with an estimated 1,636 facilities already investigated this year following a […]
CBP Liquidated Damages, Penalties, & Fines…oh my!
How to Avoid and Mitigate U.S. Customs Liquidated Damages and Penalties Did you know that U.S. Customs can assess penalties up to 3x the value of goods if you fail to export or destroy FDA refused merchandise timely? On top of FDA compliance concerns associated with FDA detained and ultimately refused goods, numerous other costs […]
Mid-Summer Grillin’! Fire up the…Cell Incubator?
FDA and USDA Regulatory Updates on Lab Grown Meat Summer is synonymous with time at the beach, popsicles and grilling. But soon enough, you may be picking up cell-grown meat on your next grocery run. The U.S. Department of Agriculture (USDA) recently approved two companies, Good Meat and Upside Food, to sell lab-grown and cell-cultivated […]
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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.