FDA WARNING_LETTER - ShangRao Chunyu Technology Co., Ltd. - September 08, 2020

The FDA issued a Warning Letter to Shangrao Chunyu Technology Co., Ltd. following the detention and refusal of admission of their "Instant – Hand Sanitizer – Moisturizing" product into the U.S. FDA testing revealed the product, labeled to contain 75% ethanol, only contained an average of 58% ethanol volume/volume, falling below the CDC's recommended minimum of 60% and violating its label claim. This renders the product adulterated under section 501(c) of the FD&C Act.

Furthermore, the subpotency indicates a failure of the firm's quality assurance to meet Current Good Manufacturing Practice (CGMP) requirements, making the product adulterated under section 501(a)(2)(B). The firm's submitted test method for finished hand sanitizers was deemed unsuitable for products containing ingredients other than ethanol and water, violating 21 CFR 211.160(b).

The FDA placed all drugs from the firm on Import Alert 66-78 on November 6, 2020. The letter requires a detailed investigation into the subpotency, a list of all raw materials and suppliers, a list and reconciliation of all batches shipped to the U.S., third-party analysis for ethanol content for all U.S.-distributed batches (with an action plan for OOS batches), complete batch records, and a comprehensive independent assessment and remediation