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Tag: Enforcement

FDA Releases Updated Draft Guidance

09/28/2023

On the Preventive Controls for Human Food Rule, Food Allergen Program and Acidified Foods

Staying true to its promise, the FDA announced the release of updated draft guidance this week to assist food facilities to comply with the requirements for current good manufacturing practices (cGMPs) and preventive controls for human food under the Food Safety Modernization Act (FSMA). Specifically, FDA’s draft guidance provides new chapters on ways manufacturers can […]

Avoid Blushing and Don’t Let GMP Violations Add to Your Highlight

09/20/2023

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

09/07/2023

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!

07/21/2023

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?

07/13/2023

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 […]

FDA Releases Update for the FDA Foods Program

07/10/2023

Update to FDA’s 2023 Priorities for Foods FDA Releases Update of Priority Guidance Topics for the FDA Foods Program In efforts to provide continued transparency for stakeholders regarding foods program priorities, FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and the Office of Food Policy and Response (OFPR) released an updated list of draft […]

Summer is for Vacation, not Detention: A Guide to Avoiding FDA Import Refusal and Detention

06/14/2023

You import a product to the U.S. and then receive a notice from your customs broker that the shipment has been held by the FDA. Next, you receive a Notice of FDA Detention right when you are about to fulfill a huge Purchase Order. Now what? Is the shipment lost in FDA space or can […]

Protecting Your Sunny Side Up

06/06/2023

A Look at FDA’s Regulation of Sunscreen FDA has regulated sunscreen since the 1970s to ensure that consumers have access to safe and effective sun protection products, but not all sunscreens are created equally! As there have been several developments involving sunscreen regulation in the past few years, we’ll provide an update as to where […]

USDA Ushers Organic Regulation Changes for the First Time in Over 30 Years

01/26/2023

Closing Gaps, Protecting Organic Producers and Improving Transparency and Traceability of Organic Products As the “organic” section of many grocery stores continues to grow, with consumers wondering and hoping that their exchange of top dollar means safer food, USDA’s passage of a new rule aims to help deter and detect fraud and protect organic integrity […]

How to Prepare and Execute an FDA Regulated Recall

01/19/2023

Protecting Consumers, Limiting Supply Chain Disruption and Avoiding Business and Reputation Damage Quickly and Effectively With product recalls consistently being in the news over undeclared allergens, bacterial contamination, physical hazards, potential of a product’s failure to conform to a performance standard, and many other reasons, consumer’s health and safety are naturally at stake. Companies also […]

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R.G. Client

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.

Mike H. Client

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.

Dr. Sastry Client

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.

Claire P. Client