Improper 483 responses

This company was inspected by FDA and received several common 483 violations, such as improper specifications and not having written procedures for cleaning and product returns.
 
🔷 From my reading of this warning letter, they could have probably avoided the GMP-related letter if they had responded correctly. People like Marian Boardley and Tara Couch can help with 483 responses. Here is FDA’s response to a poor 483 response.
👉 From warning letter. “we are unable to evaluate your corrective action because you have not provided revised “Raw Materials Spec Sheet” for the components used in the manufacture of the …. dietary supplements, nor have you provided finished product specifications for each of the products.”

🔷As with all warning letters, looking at the timing is important. The company was inspected in March and April this year and provided 483 responses in May. One month later, in June of this year, FDA reviewed the company’s website and found some violations, such as “anti-cancer” statements. They also cited the product name “Edema NatRelief” as a disease claim. Usually, product names must really push compliance boundaries to be cited, such as this warning letter from September, where the product “Full Body Antibiotic” was called out.

As I’ve spoken about in previous posts, FDA has been reviewing websites 2-8 months after inspection, which is a friendly reminder to double-check online marketing if you’ve recently been visited by FDA. This is one of the reasons I developed Apex Compliance, which helps companies find the high-risk “forgotten landmines” before they become issues. In fact, I ran Apex Compliance on their website and found even riskier claims that were not mentioned here. Removing them now can help this company avoid repeat warning letters or lawsuits.

Learn more about Apex Compliance.
 
🔷Some of the violations are scary. For example, identity testing for the Rauwolfia root ingredient was done by organoleptics rather than analytical testing. This ingredient is amazing at helping to lower blood pressure, but if the company received a Rauwolfia extract rather than the root powder, for example, this could have potentially led to a hypotensive (low blood pressure) crisis.
 
Read the full warning letter.

Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading.