FDA WARNING_LETTER - The Richline Group Inc - April 16, 2025

The FDA issued a Warning Letter to The Richline Group, Inc. following an inspection of their Tamarac, FL facility from March 24 to April 16, 2025. The inspection identified significant, including repeat, violations of the Food, Drug, and Cosmetic Act related to the firm’s Inverness Ear Care Antiseptic, Inverness Ear Care Solution, and Inverness Home Ear Piercing Kit products. A primary violation cited the firm for marketing the Ear Care Antiseptic and Ear Care Solution without required marketing authorization. Depending on product claims, these products are regulated either as medical devices requiring a 510(k) clearance or Premarket Approval (PMA), or potentially as drugs needing an approved new drug application. Without such authorization, the products are deemed adulterated and misbranded. Additionally, the inspection revealed violations of the Quality System Regulation (21 CFR Part 820), rendering the products adulterated. Specifically, The Richline Group failed to establish and maintain adequate design control procedures (21 CFR 820.30(a)) for its products, lacking essential design documentation and proper validation for product expiration dates. The FDA requires the firm to obtain proper marketing authorization for its products and implement a compliant quality system, particularly addressing the deficiencies in design controls and stability testing. The firm"s prior responses regarding these observations were deemed insufficient.