Warning Letter Wednesday® Posts

A weekly exploration of FDA warning letters and enforcement trends

February 22, 2023

Animal Product Claims Under Increased Scrutiny

Takeaway -

Old social posts are “active” marketing

Claims made about animal products seem to have a lower tolerated “acceptance level” than human products. This is a friendly reminder to take another look at your animal product marketing ...
February 15, 2023

GMP Violations Continue to be Cited in Warning Letters

Takeaway -

Hire experts to help with 483 responses

FDA continues to issue more warning letters to companies that do not adequately respond to 483 violations. The violations and 483 responses provide excellent learning opportunities. Here are some key ...
February 8, 2023

Incomplete 483 Responses Lead to Warning Letter

Takeaway -

Key GMP learning opportunities explored

We can learn a lot from warning letters. This manufacturer was inspected in April 2022, where they received some 483s. The company subsequently responded to some 483s, but according to ...
February 1, 2023

FDA Crackdown on Monkeypox Claims

Takeaway -

Learning from other’s mistakes is a good strategy

FDA sent five warning letters this week to companies selling products for Monkeypox. This is a clear violation, but there are some critical learning lessons here. Sign up for the ...
January 25, 2023

Labeling Errors Lead to Warning Letter

Takeaway -

Nutrient content claims must be compliant

This warning letter resulted from a GMP inspection and label review. Several labeling errors are cited in this letter, which are excellent learning lessons. FDA has clear requirements for nutrient content claims ...
January 4, 2023

Biomarker Claims Lead to Warning Letter

Takeaway -

Expect arterial health claims to be cited in the future

Blood sugar support claims continue to be cited in warning letters. This letter includes biomarker claims such as “improved blood sugar sensitivity and lower A1C.” Based on recent warning letters, ...
December 28, 2022

GMP Inspection Leads to Online Scrutiny

Takeaway -

Study citations are marketing

This is another example of a GMP inspection leading to a website and social media review. The initial FDA inspection was in April this year, but the website was not ...
December 21, 2022

Website “About Us” Claims Cited in Warning Letter

Takeaway -

Discussing ingredient benefits is marketing

This warning letter cites claims made in the “About Us” section of the company’s website. Usually, when “About Us” claims are mentioned in warning letters, there is some hyperlinking to ...