The FDA bit into Canadian-based homeopathic pharmaceutical manufacturer Homeolab USA in a warning letter over belladonna-treated teething products that CVS pulled off its shelves last year after the agency warned they could cause hallucinations and seizures in infants.
The letter, posted today, outlined a laundry list of serious violations uncovered during a January inspection. The list included failure to adequately test the quality of some of its ingredients and not having manufacturing processes that would ensure consistent ingredient levels.
“Some of your powder blend mixtures are manufactured from ingredients that pose potentially toxic effects,” the agency said. “For example, your Infants’ Teething Tablet contains belladonna. Raritan uses this powder blend mixture to produce finished drug products for infants and children, a population vulnerable to the toxic effects of belladonna.”
Raritan provides contract manufacturer services for Homeolab USA, and late last year issued a voluntary recall of one lot each of three products, CVS Homeopathic Infants' Teething Tablet, Kids Relief Homeopathic Ear Relief Oral Liquid and CVS Homeopathic Kids' Ear Relief Liquid. The FDA hit Raritan with a warning letter in June.
During its inspection of Homeolab USA, the agency said the company failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength and quality.
Additionally, the FDA letter called out Homeolab USA over its relationship with Homeocan. In its response letter following the inspection, the agency said the company stated that “Homeolab is not a manufacturer. Homeolab is a private label distributor, which has no manufacturing capabilities,” and that that by agreement Homeocan is “a contract manufacturer for Homeolab.”
The FDA said that because the two entities share the same address, its head of quality signs email correspondence with “Homeocan Inc./Homeolab USA” and because of other shared manufacturing responsibilities the agency sees no “significant separation” and will treat the two as a single entity. It also said and that the company cannot use a contract agreement with Raritan to “delegate statutory or regulatory responsibilities to comply with CGMP.”
The agency also noted that the company prevented an inspector from taking photographs of excess material clinging to the sides of a piece of manufacturing equipment.
The belladonna-treated teething episode began almost a year ago, when the FDA issued a consumer alert warning parents to dispose of homeopathic teething tablets and gels sold by CVS, Hyland’s and others because they posed a potential risk. Hyland’s, which manufactures its own products in-house, balked at the FDA warning but later recalled its products.