A “homeopathic” company got busted for having high variances in their manufacturing process. In essence, some tablets would have the correct level of nothing, while others would have something resembling a dose. The supposed inert they were using? Deadly nightshade. The product? Infant teething tablets.
It’s probably a good thing the FDA can’t deploy armed forces. The company that did this, homeolab, would probably be a smoldering crater right now if they could. Although if you are essentially selling a pill for babies that contains fucking DEADLY NIGHTSHADE and you have no control over your manufacturing process.....You deserve it. Criminal charges should come from this. Children have died and will continue to die because these companies are run by hacks and people think homeopathy is some legit medicine. Meanwhile they have zero control or care over their manufacturing processes and show a complete disregard for science and medicine.
Two highlights from the letter here. Both show how the company is trying to weasel out of any responsibility for their processes. ANd I guarantee you plenty of other “homeopathic” remedies are made by other companies that do the same exact thing.
1) Note that when a manufacturer employs a contract facility for part of drug manufacturing (including processing, packing, holding, or testing), the manufacturer’s quality unit is responsible for approving or rejecting drug products manufactured by the contract facility, (b)(4). See 21 CFR 200.10(b) and 211.22(a). Furthermore, it is important to note that quality agreements cannot be used to delegate statutory or regulatory responsibilities to comply with CGMP. Refer also to the FDA 2016 guidance for industry, Contract Manufacturing Arrangements for Drugs: Quality Agreements
2) In your response you state, “Homeolab is NOT a manufacturer. Homeolab is a private label distributor, which has no manufacturing capabilities.” In your response you also state, “Homeocan is by agreement a contract manufacturer for Homeolab.”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. Homeolab (part of the parent company, Homeocan Inc.) is a registered manufacturer with the FDA. According to your Duties and Responsibilities document, Homeolab is responsible for “GMP Compliance with regulatory bodies” and “Approval of Batch for Distribution.” In terms of drug manufacturing, Homeolab USA Inc. and Homeocan Inc. have no significant separation, so we are treating Homeolab/Homeocan as a single entity.
Here’s a tip - don’t do either of those things! Oh and they tried blocking the inspectors form taking pictures. Another tip - REALLY DON’T DO THAT!