Warning Letters

Warning Letters

Cosmetic Labeling Violations from Recent FDA Inspections and Warning Letters (2025-2026)
ByFDA Inspections Team February 22, 2026February 22, 2026

The Modernization of Cosmetics Regulation Act (MoCRA) has transformed how the FDA monitors the beauty industry. This comprehensive guide analyzes recent cosmetic labeling violations found in 2025-2026 warning letters. Learn about unauthorized drug claims, ingredient listing errors, and safety substantiation gaps. Stay compliant with evolving FDA standards and protect your brand from costly enforcement actions.

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Warning Letters

Pharmaceutical QA: Responding to FDA 483 Observations on Sterility and Potency Controls
ByFDA Inspections Team February 22, 2026February 22, 2026

Handling FDA 483 observations on sterility and potency requires a precise technical response. This guide explores how Pharmaceutical QA teams can address regulatory findings, implement robust CAPA systems, and ensure long-term CGMP compliance. Learn to navigate complex inspections while maintaining high manufacturing standards for sterile injectable and high-potency drug products.

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Warning Letters

What FDA Pharmaceutical CGMP Inspection Trends Reveal from the Latest Warning Letters (2025-2026)
ByFDA Inspections Team February 22, 2026February 22, 2026

Stay ahead of regulatory shifts with our deep dive into FDA pharmaceutical CGMP inspection trends from 2025-2026. This comprehensive guide analyzes recent warning letters to reveal common pitfalls in data integrity, CAPA systems, and manufacturing controls. Learn how to strengthen your quality management system and ensure audit readiness in an increasingly digitized regulatory landscape.

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Warning Letters

How to Respond to an FDA Warning Letter: Strategy, Timing & Tone
ByFDA Inspections Team September 25, 2025September 25, 2025

Receiving an FDA warning letter is a critical event for any regulated company. It signals significant regulatory violations that require immediate and thorough attention. A poorly crafted response can escalate the situation, leading to severe penalties. This guide provides a comprehensive strategy on how to respond to an FDA warning letter, covering everything from the initial assessment and team assembly to the critical 15-day deadline, drafting a detailed response, and implementing effective corrective actions.

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Warning Letters

Top Reasons Medical Device Companies Receive FDA Warning Letters
ByFDA Inspections Team September 25, 2025September 25, 2025

Receiving an FDA warning letter can severely impact a medical device company’s operations, reputation, and financial stability. These letters signify serious regulatory violations that were not adequately addressed after an inspection. Understanding the common pitfalls is the first step toward building a robust compliance framework. This article explores the top reasons medical device companies receive warning letters, from inadequate CAPA systems and poor complaint handling to failures in design and process controls. Learn how to strengthen your quality system and maintain a constant state of inspection readiness.

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Warning Letters

How to Respond to an FDA Warning Letter: A Complete Guide for Manufacturers
Byplwertalik July 5, 2025July 6, 2025

Receiving an FDA Warning Letter is one of the most serious regulatory events that can occur for any manufacturer in the United States. It is not merely a slap on the wrist—it is a formal, public notice that the U.S. Food and Drug Administration has determined your facility or your products are in significant violation…

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US FDA Issues Warning Letter to Lucky Pacific Corp and Kamli International Co. Ltd.
Byplwertalik May 26, 2025July 6, 2025

On March 2, 2017, a US Food and Drug Administration (USFDA) Warning Letter was issued to seafood importers, Lucky Pacific Corp and Kamli International Co. Ltd. This Warning Letter was issued for serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation. These violations caused the ready-to-eat dried fish snacks and ready-to-eat…

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US FDA Issues Warning Letter to DeGrave Dairy for Illegal Drug Residue
Byplwertalik May 26, 2025July 6, 2025

On February 27, 2017, a US Food and Drug Administration (USFDA) Warning Letter was issued to the two owners of DeGrave Dairy. This Warning Letter was issued for violations of the Federal Food, Drug, and Cosmetic Act (the Act). DeGrave Dairy is a dairy operation that the Minneapolis District inspected for three days. The violations included –Presence…

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