Tag: Warning Letters
Documentation Alone Is Not Enough
The FDA continues to aggressively enforce the Foreign Supplier Verification Program (FSVP) , and its most recent Warning Letters reveal a common theme: importers are being cited not simply for lacking paperwork, but for failing to demonstrate meaningful oversight of their foreign suppliers. Recent Warning Letters issued to Datil Fresh Produce LLC, Moda Food LLC, […]
When Marketing Becomes Regulation
For many consumer brands, the package receives careful legal review while the website is treated as “marketing.” From an FDA perspective, that distinction can be dangerous. FDA evaluates representations made about regulated products when determining issues such as intended use, product classification, labeling , and whether a product is being marketed in violation of the […]
How to Avoid Escalation to a Warning Letter
An FDA Form 483 is not routine. It’s the moment your inspection outcome is decided. Across food, supplements, OTC drugs , cosmetics, and medical devices, recent enforcement shows a clear pattern: your response—not the inspection—often determines whether you escalate to a Warning Letter. What a 483 Really Means A Form 483 signals FDA believes your […]
Power, Pitfalls, and the Non-Negotiable Role of Human Review
Artificial intelligence is rapidly transforming FDA-regulated industries—but it is also quietly reshaping regulatory risk. Companies across food, beverage, dietary supplements, OTC drugs, cosmetics, and medical devices are now using AI to draft submissions, generate SOPs, review labels, and analyze safety data. At the same time, FDA itself is deploying AI to accelerate review, inspections, and […]
FDA’s Valentine’s Day Reminder for OTC Drug Claims
Valentine’s Day is peak season for self-care. Consumers are encouraged to love themselves a little harder, sleep a little better, feel a little calmer, and look a little brighter—preferably by picking something up from the drugstore endcap wrapped in pink and red packaging. For OTC drug manufacturers, however, February also brings a familiar reminder from […]
Format Risk in the Era of Foodified Beauty
The consumer-beauty/personal‐care sector is operating in what one might call a “regulatory + innovation squeeze”-zone. On one hand, major regulatory enforcement activity is underway — particularly from the FDA’s Center for Drug Evaluation and Research (CDER) — which signals heightened agency focus on non-traditional dosage forms, claims and cross-category blur. On the other hand, brand […]
The FTC’s July 2025 Crackdown on “Made in USA” Claims Puts Industry on Notice
A Patriotic Primer Turned Compliance Crossfire As barbecues sizzled and flags fluttered this July 4th, the Federal Trade Commission (FTC) was busy preparing a fireworks display of its own—this one of the regulatory variety. Declaring July as “Made in USA Month,” the Commission followed up its symbolic gesture with real regulatory firepower: four warning letters […]
A Look at Audit Readiness in the Age of Expanded Inspections
The FDA is back in full swing, and inspections—both scheduled and surprise—are becoming more frequent, more detailed, and more critical than ever. As global regulators expand the scope, frequency, and depth of inspections, companies face increasing pressure to demonstrate compliance and transparency. Expanded inspections, whether triggered by legislative updates, whistleblower complaints, or routine agency policy, […]
FDA Announces Expanded Use of Unannounced Foreign Inspections
In what can only be described as the regulatory equivalent of “We were in the neighborhood…”, the U.S. Food and Drug Administration (FDA) announced May 6, 2025, its expanded use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines and other medical products intended for American consumers and patients. Yes, you read […]
Navigating the FDA’s High Seas of Foreign Supplier Verification Program (FSVP) Inspections
Ahoy, mateys! Batten down the hatches and hold onto your manifests, because the FDA’s on the prowl, issuing Warning Letters like they’re going out of style! If you’re in the business of importing FDA-regulated products, particularly food, you’re probably well aware of the Foreign Supplier Verification Program (FSVP). And if you’re not—well, now’s the time […]
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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.
