FDA News: Things Just Changed

By Mike Grubb, President & CEO

If you use natural products in your practice, then you’re probably following the long-term story about a shift in the FDA’s regulation of homeopathy.

In the context of that story, and as a leading supplier of high-quality homeopathic remedies to US healthcare professionals, we routinely analyze FDA warning letters. It’s one way we work to understand the FDA’s priorities and posture toward our industry.

So, just a few short weeks ago, I wrote that “the FDA has issued more than 50 warning letters related to homeopathic products since 2017, but only two in the last year and NONE in the last six months.”

That was true when I wrote it. But things just changed.

A new homeopathy-related warning letter was just posted on the FDA website, and it’s a doozy.

Among other things, the company (Healwell) was cited for the following:

Live rodents, birds, and insects in and around the production facility. Inspectors found animal feces, feathers, live birds and rodents, insects, and even a stray dog.

Product components were in filthy conditions. Raw materials and packaging components were kept in uncovered drums coated with dust, cobwebs, and rodent droppings.

No ID testing of incoming ingredients. Ingredients were accepted and used without being quarantined, tested, or otherwise confirmed for quality. The company relied entirely on supplier certificates of analysis (COAs) without verification.

No written procedures for key quality operations. The company lacked written procedures for essential operations, including cleaning, staff training, equipment use, and labeling.

No process validation or equipment qualification. There was no documentation that manufacturing processes or cleaning procedures had been validated, or that instruments used in production had been calibrated.

No batch production records or oversight systems. The company failed to maintain or review batch records, leaving no assurance that its products were consistently produced according to required quality standards.

Unfortunately, these are the kinds of quality issues that give homeopathy a bad name.

Producing high-quality products isn’t like cramming for a college exam. You don’t pass by pulling an all-nighter. Quality is earned through daily discipline and hundreds of small, consistent decisions.

These are just a few of the details we attend to daily.

We maintain strict control over facility hygiene and pest prevention with cleaning protocols and pest control programs designed to protect production areas from any form of contamination.

We store ingredients and other components in areas and containers that protect them from dust, moisture, and cross-contamination, with documented traceability from origin through use.

We source carefully and test every active and inactive ingredient using validated methods to confirm identity and purity. We never use an ingredient, container, or closure without ensuring it matches specifications.

We carefully vet suppliers and regularly validate the accuracy of their documentation through third-party, ISO-certified testing.

We maintain and follow documented Standard Operating Procedures (SOPs) that govern every aspect of our operation, including manufacturing, cleaning, training, calibration, recordkeeping, and packaging.

We use third-party testing to validate our production processes and cleaning protocols to ensure their accuracy and effectiveness. Equipment is regularly maintained, calibrated, and cleaned after every use according to validated protocols.

We maintain complete and accurate batch production records. Every record is reviewed by the quality unit before the product is released, and detailed records are retained for complete traceability.

We train our team members upon hire and on an ongoing basis to ensure they understand and follow quality procedures.

We maintain a proactive quality assurance and internal audit system designed to identify gaps, correct issues, and improve systems over time.

We do all these things – and more – because your work deserves it.

We’re not perfect, but we’re proud of our quality record. We make the right decisions every day—even when they’re hard or costly—because your patients rely on you, and you rely on us.

We’ll continue monitoring regulatory developments and doing the hard work behind the scenes so you can focus on caring for patients with confidence.

Mike Grubb
President & CEO