Importance of Product Specifications

There seem to be three major issues in this dietary supplement warning letter. Inadequate product specifications, lack of documentation, and incomplete 483 responses. Let’s see what we can learn.

Inadequate product specifications:

From warning letter. “Your “(b)(4)” document for your Ashwaghanda Gummies lists appearance, color, odor, and water activity as “(b)(4).” These factors do not constitute unique criteria that can confirm the identity of the Ashwaghanda Gummies product. Additionally, these factors do not—either alone or in conjunction—evaluate the purity, strength, and composition of this finished product.”

Asa comments: The tests they are doing, such as water activity, are a good starting point, but they are far off from required testing, such as identity, potency, and microbials.

Lack of documentation:

From warning letter. “You failed to make and keep documentation of any material review and disposition decision and follow-up, as required by 21 CFR 111.140(b)(3). Specifically, your Senior Quality Manager stated that when “(b)(4)” results had been encountered by your firm since your last inspection for incoming components and outgoing dietary supplements, you failed to document the investigation, findings, material review by quality, and the disposition of affected materials.”

Asa comments: Documentation is a core part of GMP supplement manufacturing, and it seems that little to no documentation was being done. Wow, just wow!

Incomplete 483 responses:

From warning letter. “We have reviewed your response to the FDA Form 483, received February 5, 2025, and find it does not adequately address the violation. In your response, you stated that you plan to update finished product specification forms for the finished dietary supplement products you manufacture, including Immune Support and Ashwagandha Gummies. However, to date, you have not submitted any evidence of further corrective action.”

Asa comments: This one is pretty obvious, as it seems the company never responded to this 483. In my opinion, this warning letter could have been avoided with complete and documented 483 responses.

The timeline seems a bit odd to me. FDA inspected the facility from November 19, 2024, through January 13, 2025, which is a LONG inspection. The company then provided 483 responses in February 2025, and there seems to have been little to no communication (according to the warning letter) until the warning letter was issued seven months later. Oftentimes, there is back-and-forth on 483 responses. This may be due to a lack of documentation, and the incomplete 483 responses were so egregious that the FDA felt this warranted a warning letter. If I am missing something, please let me know.

There are also more comments about low-acid canned foods. Read the warning letter.