FDA WARNING_LETTER - Ningbo Pulisi Daily Chemical Products Co., Ltd - February 28, 2019

The FDA issued a Warning Letter to Ningbo Pulisi Daily Chemical Products Co., Ltd. following an inspection from February 25-28, 2019, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated. The company also manufactures misbranded products, including Foaming Acne Scrub (misbranded under 502(c) for incomplete statement of identity) and several AuraFresh Hand Sanitizers, HALSA SHAMPOO, and SPA MYSTIQUE products (misbranded under 502(x) for lacking a domestic address/phone number for adverse event reporting).

Key violations include: 1. Failure to perform adequate laboratory testing for each batch of drug product, including identity and strength of active ingredients (e.g., zinc pyrithione, salicylic acid) and microbial attributes, prior to release (21 CFR 211.165(a) and (b)). 2. Failure to conduct identity testing for each component and validate supplier test analyses (21 CFR 211.84(d)(1) and (2)). 3. Failure to follow an adequate written stability testing program to support product expiry dates (21 CFR 211.166(a)). 4. Failure to establish written procedures for production and process control, specifically lacking validation of manufacturing processes (21 CFR 211.100(a