China NMPA Drug Inspection - Puning Baicao Traditional Chinese Medicine Pieces Co., Ltd. - Buddha's Hand

This document from the Guangxi Zhuang Autonomous Region Food and Drug Administration, dated December 28, 2017, and published January 3, 2018, details the outcomes of recent drug quality sampling inspections. The inspections targeted drug production and distribution enterprises, as well as medical institutions within its jurisdiction, under the Guangxi Drug Sampling Plan.

The inspection identified 21 non-compliant drug batches: 3 drug preparations and 18 traditional Chinese medicine decoction pieces. Specific violations for preparations included issues with substance content (e.g., Chloramphenicol Drops from Guangdong Hongying Technology), moisture levels (e.g., Capsules from Inner Mongolia Tianqi Pharmaceutical), and product properties (e.g., Compound Fritillaria cirrhosa from Guangxi Banzhou Dakang Pharmaceutical). For traditional Chinese medicine decoction pieces, widespread issues observed across multiple manufacturers included non-compliant content determination (e.g., Chuanxiong, Cassia Seed), improper properties or appearance (e.g., Bupleurum, Trichosanthes Seed, Duckweed), non-compliant extract (e.g., Vinegar-processed Sparganium), and unacceptable sulfur residue levels (e.g., Chicken Gizzard, Lily). These findings were based on criteria from the Chinese Pharmacopoeia and National Drug Standards.

In response, the administration has initiated necessary control measures, including sealing, seizing, and suspending the sale of the substandard drugs. Further legal investigation and punitive actions against the responsible entities are also mandated.