Batch Production Record & Labeling Lessons
Re-review websites if inspected by FDA
This company is a small manufacturing facility and storefront that is reminiscent of the companies I would order herbs from in the 1990s. Since then, herbal regulations have matured, but unfortunately, this company has not evolved into the highly regulated world of herbal supplements.
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🔷This letter contains serious GMP violations such as not having specifications and providing incomplete 483 responses like “(we) are still in the process of establishing and implementing the systems.” It also contains many serious online disease claims, and this letter exemplifies how a well-intentioned herbal store can become non-compliant. This is a cautionary tale about the complexities and penalties for companies looking to manufacture and market herbal products.
🔷The disease claims cited in this letter are numerous, but I’ll focus on what we can learn from Batch Production Record GMP violations. I suggest everyone read the full warning letter. You can also comment or message me with specific questions or commentary.
🔷Batch Product Record (BPR) lessons from this warning letter.
🔹Date/time of equipment maintenance, cleaning, and sanitizing record
🔹Statement of actual and theoretical yield. This is how manufacturers can find issues before products ship. For example, if the theoretical yield is off, this signals that too much or too little of an ingredient was added.
🔹Date and initials of each person weighing and verifying component weights.
🔹Labels: The unique identifier assigned to packaging and labels used, the quantity of the packaging and labels used, and, when label reconciliation is required, reconciliation of any discrepancies between issuance and use of labels.
🔷More labeling issues are cited in this warning letter, such as not listing the Latin or the standardized common name of plants as noted in American Herbal Products Association (AHPA)’s Herbs of Commerce, or listing the plant part (e.g., root). These did not lead to the warning letter, but we can learn about labeling best practices. For example, indenting the ingredients under a proprietary blend is apparently a rule.
From warning letter. “Dietary ingredients are not indented under the title “Proprietary Herbal Blend”
🔷FDA reviewed this company’s website a few months after the initial inspection. This is a reminder for all companies to re-review their online marketing if they have been recently inspected. This may save you from getting a warning letter. This is one of the reasons I invented and patented Apex Compliance.
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.