GMP Inspection Leads to Website Review
Product names are marketing terms
It is important to respond to FDA 483 requests before they lead to a warning letter. In this example, the company was inspected and issued a 483 by FDA in December. The company never responded! Then, four months later, FDA reviewed their website and found some serious disease claims, which led to a warning letter.
Why not respond to a 483? I do not understand the logic of not trying to address the issue with FDA. In my experience, most 483s can be “handled” before they lead to a warning letter.
Reviewing online content for disease claims is an essential part of compliance. This is especially true for companies that have been inspected by FDA. Expect them to look at online content, even the very old stuff which is still considered active marketing in the eyes of the FDA.
A few more learning opportunities here. I am sometimes asked if softening language such as “may” helps reduce risk. This answer, as they say, in Australia is “naur.” Here is a great example.
From warning letter. “May Lower Blood Pressure”
Product names are also considered marketing. Here’s a perfect example of what not to do.
From warning letter. “Name of product is a claim “Arthritis Bursitis Rheumatism””
Now let’s move on to some of the GMP violations.
Theoretical yield: This is an important part of GMPs that I call the lily-pad approach, meaning weights should be checked to ensure they are within specification before they get to the next step of the process. I’ve seen a lot of mistakes, such as missing ingredients, double-counted ingredients, incorrect weights (e.g., using kilos instead of pounds), overfilled capsules, and underfilled bottles. The theoretical yield helps catch issues before they reach the next step in production or shipping to customers.
From warning letter. “A statement of theoretical yield of a manufactured dietary supplement expected at at the mixing, encapsulating, and packaging stages of the manufacturing process”
Cleaning logs. The adage “If it’s not written down, it didn’t happen” holds true here.
From warning letter. “The time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch, or a cross-reference to records, such as individual equipment logs, where this information is retained”
There’s a lot more to this letter, and I invite you to give it a read.
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