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The agency is warning these manufacturers that they are putting consumers at risk with substandard manufacturing practices.
On May 14, 2019, FDA announced it had sent warning letters to Kadesh Inc., U.S. Continental Marketing, Inc., Fill It Pack It, Inc., Bershtel Enterprises LLC, and Newton Laboratories for violations of current good manufacturing practices (CGMPs). The companies all produce homeopathic products that the agency says put consumers at risk.
Four of the companies that received the warning letters (Kadesh Inc., U.S. Continental Marketing, Inc., Fill It Pack It, Inc., and Bershtel Enterprises LLC) do business as WePackItAll and jointly manufacture and package Puriton Eye Relief Drops. After testing samples of the product, the agency found the eye drops were non-sterile and had a high pH level, which could lead to eye injuries. Specifically, the warning letters detailed a lack of a quality control unit, incomplete batch production and control records, failure to establish written procedures to prevent microbiological contamination, and failure to investigate batch failures, among other quality control issues.
The fifth warning letter, sent to Newton Laboratories, detailed CGMP and misbranding violations for human and animal drugs. “Some of the company’s products labeled as homeopathic are indicated for treating conditions in infants and children, and they are manufactured from ingredients such as nux vomica, belladonna, aconitum napellus, and gelsemium sempervirents that pose potentially toxic effects. For example, nux vomica contains strychnine, which is a highly toxic, well-studied poison that is used to kill rodents. Producing such a product without proper manufacturing controls may lead to super-potent drugs, which could be a potential poisoning risk for consumers,” FDA stated in a press release.
“It’s our public health obligation to protect consumers from unsafe products. Our manufacturing requirements are designed to ensure the quality and safety of drugs distributed to American consumers, and the FDA expects companies to manufacture and label their products appropriately,” said FDA Acting Commissioner Ned Sharpless, MD, in the press release. “When products labeled as homeopathic are contaminated or contain potentially harmful ingredients, we will take action so consumers are not put at risk.”