Warning Letter Wednesday Posts

Another Amazon warning letter, this time for distributing products apparently intended for injection, such as the “L-Carnitine Body Serum Ampoule.” This is part of a group of at least six ...

Following specifications prevents greater issues High lead recall alert! A dietary supplement company in New York issued a recall for its finished product, Shatavari, due to high lead levels. Greetings ...

Disclosing material connection is essential for compliance Lessons in endorsement guidelines. Celebrity Kevin Hart came under the scrutiny of the National Advertising Division’s (NAD) monitoring of endorsement disclosure compliance. These ...

Take FDA inquiries seriously Being unresponsive to official FDA requests can lead to serious issues. A drug manufacturing facility in India received a records request from FDA. After several attempts, ...

Ensure ESG claims are substantiated We love the environment, but companies making broad sustainability claims are asking for increased scrutiny. This is because statements like “environmentally friendly” and “sustainably sourced” ...

Small issues signify deeper noncompliance Dietary supplement labeling can be confusing, but ensuring that the “small things” like line thickness are compliant is important. When FDA looks at a label ...

Small words can drastically increase claim risk A children’s brain health applesauce product received a National Advertising Division inquiry for cognitive and immune-related claims. This is an important reminder that ...

Ensure 483 responses are complete This letter is a great reminder of the basics of Good Manufacturing Practices, starting with developing specifications to ensure the ingredients and products are correct ...

Safety related product claims attract scrutiny Making a “Certified Non-Toxic” claim on a mouthwash triggered a competitor challenge. According to the National Advertising Division (NAD) comments, the substantiation provided by ...

Amazon compliance still needs improving Six animal product companies received warning letters for making seizure, cancer, and other serious disease claims on Amazon, social media, and websites. You may be ...

Trustpilot reviews can be “marketing” CBD in tampons? During a GMP inspection at this company’s facility in Bulgaria, FDA determined that CBD is a drug product that deems the tampons ...

Be nice to FDA investigators & follow inspection SOPs GMP inspection preparedness is an essential part of business and compliance. This includes ensuring team members know how to conduct themselves ...