- The Food and Drug Administration has issued a warning letter to a Canadian homeopathy company for the way in which it produces powder blends.
- The warning letter stemmed from a January inspection of Homeolab Inc., part of the larger Homeocan Inc., which found that the drugmaker used "inherently variable processes" when making in-process powder blends before sending them off to Raritan Pharmaceuticals Inc., a U.S.-based contract manufacturing organization (CMO).
- Of particular concern to the agency was that some of Homeolab's products contain potentially toxic ingredients like belladonna, which the company uses in its teething tablets. The FDA, therefore, recommended Homeolab tap a consultant who could help get production aligned with current good manufacturing practices (cGMP).
This latest warning letter, dated Aug. 2, is the FDA's 32nd for manufacturing quality issues since the start of 2017. Conversely, the agency had sent out just 17 by the same time in 2016 — indicative of a trend toward stepped-up oversight of manufacturing and supply chains.
Homeolab's warning letter is noteworthy, though, because the company is headquartered in Montreal, Canada. More commonly, the FDA has found problems with drug manufacturers in Asian countries such as China and India.
The FDA found a number of problems at the Homeolab production site during its inspection. For one, a company consultant prevented one of the investigators from taking photos of a piece of equipment that had excess material hanging from it, according to the warning letter. The agency also took issue with contract agreements between drugmaker and Raritan, reminding Homeolab that its quality unit is the one responsible for ensuring all product coming from the CMO meets standards.
The most important observation was that Homeolab didn't have proper protocols in place to assess the quality of its homeopathic in-process powder blend mixtures. During an inspection of Raritan that happened between September and October 2016, for instance, the FDA found that at least one lot of Homeolab's in-process drugs did not have the same composition.
In a response letter, the FDA requested Homeolab provide details of a program that would address the quality-control issues in its processes, as well as a risk assessment for distributed products made with in-process powder blend mixtures.
Homeolab had sent a previous response to the agency in late January follow the site inspection. The company attemtped to defend itself, according to the FDA by stating "Homeolab is NOT a manufacturer. Homeolab is a private label distributor, which has no manufacturing capabilities," and adding that Homeocan is a contract manufacturer for Homeolab.
The FDA, however, wasn't biting.
"Homeolab USA Inc. and Homeocan Inc. share the same address, facility, and personnel, including the chief executive officer and the head of quality. Your head of quality signs email correspondence with "Homeocan Inc./Homeolab USA" as your firm’s identity ... [i]n terms of drug manufacturing, Homeolab USA Inc. and Homeocan Inc. have no significant separation, so we are treating Homeolab/Homeocan as a single entity," the agency said in the waring letter.