Lab Test Suitability Enforcement
Complete 483 responses can prevent warning letters
GMP violations such as identity and other specifications continue to be cited in warning letters.
Testing suitability and Incomplete 483 responses:
Most companies can “walk back” or address 483s before they lead to warning letters. In this warning letter FDA seemed to give the company multiple chances of compliance but after six responses FDA added it to the warning letter. Developing a position paper to support the testing suitability would have likely prevented this section of the warning letter. To all my lab folks, what is the best way to show the suitability of the testing method?
From warning letter: “You rely on a third-party laboratory to conduct your pathogen testing for finished products. Your third-party laboratory said they did not determine the suitability of the following methods for testing.
From warning letter: “Your responses dated 12/06/24, 1/31/25, 2/28/25, 3/31/25, 5/30/25, and 6/30/25 include updated finished product microbial testing specifications. However, we are unable to evaluate the adequacy of your response because you did not provide supporting documentation demonstrating that you have verified that such tests are appropriate for their intended use in your products.”
Identity Specifications:
This company makes a greens product with over 80 ingredients which seems like an identity testing nightmare. According to the warning letter, the company tested 18 of the 80+ ingredients for identity, “which is not adequate to establish identity for each batch of the dietary supplement.” In the warning letter, it states that the company did not have acceptance criteria written on the specification form, which speaks to the adage of Good Manufacturing Practices: if it’s not written down, it didn’t happen.
Read the letter here.
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