FDA WARNING_LETTER - Jiangmen Nowadays Daily Goods Co., Ltd. - March 09, 2017

The FDA inspected Jiangmen Nowadays Daily Goods Co., Ltd. from March 6-9, 2017, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Failure to test drug products:** OTC drug products were released without adequate testing for identity and strength of active ingredients (21 CFR 211.165(a)). 2. **Failure to test components:** Incoming active pharmaceutical ingredients and other components were not tested for identity, purity, strength, and quality, relying solely on unqualified supplier certificates of analysis (21 CFR 211.84(d)(1),(2)). 3. **Inadequate equipment design/maintenance:** The water system used in OTC drug products was not adequately designed, controlled, maintained, or monitored to ensure it consistently produced water meeting USP monograph specifications and microbial limits (21 CFR 211.63). 4. **Lack of process validation:** Manufacturing processes for OTC drug products were not validated, lacking qualification studies and an ongoing program for monitoring process control (21 CFR 211.100(a)).

The FDA deemed the company's March 28, 2017, response inadequate. Required corrective actions include providing detailed test methods and specifications for drug products and components, timelines for testing in-date products, plans for water system validation, and timelines for