![]() ![]() With new money, new digs, and new obstacles ahead of them, Guilbert, Alvarez, and co. ![]() Guilbert said the company’s retail partners and distributors have been steadfast in their support and commitment to Harmless Harvest as it works towards meeting those requirements. “The FDA’s getting us to do improvements and this is the way they communicate formally and we’re responding formally. “This is their process,” Guilbert said of the warning letter. Alvarez said that she has been involved with the agency in regular discussions to substantiate the company’s methods. While Harmless Harvest is most wary of maintaining a supply chain capable of keeping the product refrigerated throughout manufacture and sale, it is currently attempting to devise, with the FDA, a way to show that its proprietary processes - which include a mix of micro-filtration and HPP - can prevent spores from getting into the product. Nevertheless, the company will spend the winter making the necessary “process enhancements” to both the new and old facilities to meet the FDA’s requirements regarding the validation of critical limits to control microorganisms. Guilbert and Alvarez clarified that the company’s decision to pause bottling operations at its existing plant was already in the works prior to the FDA’s warning letter and that the temporary suspension was not a result of the regulatory compliance issues. Still waiting for resolution, however, is the company’s issues with the FDA. According to Alvarez, the space will be 10 times larger than the company’s existing plant, allowing Harmless to gradually increase its operations within it over time as additional capacity becomes required to meet consumer demand. The new funding will also go towards the development of Harmless’ new production plant in Thailand. ![]()
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