FDA WARNING_LETTER - FairyGene Inc - January 15, 2026

The FDA issued a warning letter to FairyGene, Inc. following an inspection of its Bristol, Pennsylvania facility from January 12 to 15, 2026. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations, rendering the company’s drug products adulterated under the Federal Food, Drug, and Cosmetic Act. Key issues included a facility environment unsuitable for drug manufacturing, characterized by inadequate ventilation and haphazard material storage that risked product contamination. Additionally, the firm failed to establish proper equipment cleaning protocols; investigators found that the water system used for cleaning frequently exceeded microbial limits, and the company lacked the logs necessary to verify sanitization activities. The FDA also identified several products, such as those under the FROYA and Norse brands, as unapproved new drugs and misbranded products. These items made medicinal claims for treating conditions like rosacea, acne, and eczema without meeting the requirements of established over-the-counter monographs or possessing approved drug applications. Furthermore, the company’s Quality Unit was found deficient in its oversight of production controls and stability testing programs. FairyGene is required to respond within 15 working days with a comprehensive remediation plan. The FDA strongly recommended hiring a qualified consultant to perform a full audit of operations and ensure future compliance with regulatory standards. Failure to correct these violations may lead to legal action, including product seizures or injunctions.