FDA WARNING_LETTER - Guangzhou Baiyunshan Pharmaceutical Co., Ltd. - May 25, 2017

The FDA inspected Guangzhou Baiyunshan Pharmaceutical Holdings Co. LTD's Baiyunshan Hejigong Pharmaceutical Factory in Guangzhou, China, from May 22-25, 2017, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated. The firm's June 19, 2017, response was deemed inadequate.

Violations include: 1. Failure to properly clean and maintain equipment: A "clean" piece of equipment used for two different products contained significant material and product residue. The firm's response blamed employees and management but failed to evaluate cleaning procedures or assess past batches for cross-contamination. 2. Failure to follow written production and process control procedures: A master batch record lacked a specified time for a critical processing step, and a timer malfunctioned during a demonstration. 3. Failure to establish reliability of component supplier analyses: The firm could not identify the manufacturer of a critical raw material and lacked sufficient systems to qualify raw materials. 4. Failure to follow written procedures for component handling: Uncontrolled component release stickers were found in the warehouse, risking the use of unauthorized components.

The FDA strongly recommended engaging a qualified CGMP consultant. Additionally, the firm's OTC topical drug products, labeled for (b)(4) use, were found to contain undeclared (b)(4) components, violating labeling requirements (21 U.S.C.