FDA WARNING_LETTER - Ningbo Riway Industrial Co., Ltd. - May 13, 2025

The FDA issued a Warning Letter to Ningo Riway Industrial Co., Ltd. on April 30, 2025, following a review of records submitted per a March 11, 2024, request. The facility, an OTC drug manufacturer, was found to have significant Current Good Manufacturing Practice (CGMP) violations, rendering its drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Failure to test component identity:** The firm did not adequately test incoming components like (b)(4) and isopropyl alcohol (IPA) for identity or hazardous impurities (e.g., (b)(4) for (b)(4), methanol for IPA), and accepted supplier COAs without verification (21 CFR 211.84(d)(1) and 211.84(d)(2)). 2. **Inadequate finished product testing:** The firm failed to conduct appropriate laboratory tests for active ingredient content, impurities, and microbiological quality (for sterile products) before releasing drug products (21 CFR 211.165(a)). 3. **Deficient Quality Control Unit:** The Quality Unit (QU) did not effectively oversee drug manufacturing, failing to ensure proper water system design/monitoring for sterile products and adequately approve/reject components (21 CFR 211.