The FDA has told a British maker of homeopathic medicines that some of its products, which anyone can buy off Amazon, qualify as prescription drugs under FDA rules. It also says manufacturing at the company's Wimbledon plant in London comes up short.
In a July 26 warning letter just posted to the FDA site, the agency tells A Nelson & Co. that about 1 in 6 vials on the fill line appeared to be overfilled or underfilled because of vibration on the line. Inspectors also saw glass fragments around open vials on the fill line and said the company appeared to have no set procedures for cleanup when there is breakage.
The agency was unimpressed with the company's response that there have been no complaints about glass fragments in its products and that it was taking steps to address both problems. Instead, the FDA says Nelson needs to determine how many products might have been shipped to the U.S. that could have been affected by the problems.
"Your response is found unacceptable as quality cannot be added to a product that has been already manufactured and released for distribution," the letter says.
To the agency's observation that documentation didn't include all the necessary data, the company said that by the end of the year it would replace the notebooks it has been using with analytical test forms. But the FDA says Nelson needs to specify what will be done in the interim to guarantee that all relevant information makes it into its notebooks.
In email to FiercePharmaManufacturing, the company says: "Nelsons acknowledges receipt of a warning letter sent by the U.S. FDA. We will fully review the document and address every issue detailed within the letter in due course. Nelsons expects to satisfactorily follow up with the FDA within the period stated by the FDA."
Among the things the company must address is whether some of its products qualify as prescription drugs because labels say they are for "symptoms of rheumatoid and osteoarthritis," or other conditions that can only be diagnosed by a physician.
Whether prescription or not, homeopathic drugs fall under the FDA purview and it has found issues at some other manufacturers. For example, a November 2009 warning letter cited Washington Homeopathic Products' Berkeley Springs, WV, plant for a variety of manufacturing problems including some repeats.
- here's the warning letter
Special Report: Washington Homeopathic - Top 12 GMP Violations