Shortcomings by the Score at Chinese Drug Manufacturer, FDA Said

The FDA cited a Chinese drug and API facility for a slew of violations of agency standards, based on an inspection of the company’s plant in Tianmen.

The company, Waterstone Pharmaceuticals, specializes in production of drugs for liver and gastrointestinal diseases.

Among the 20 problems flagged by the FDA were:

• The lack of a quality management system, including the failure to evaluate the most difficult to clean and the highest-risk products, to validate testing methods for product residue, to maintain batch records for reworking materials and to write procedures in language that is clear and easy to understand. In one case, five workers could not agree on the number of tests called for in a procedure;
• Failure to examine packages of received supplies for defects or to check if the trucks used to deliver the supplies were clean;
• The absence of a program to analyze supplies to verify their quality;
• Failure to seal API packaging appropriately and to include alerts of the resulting possibility of contamination;
• Failure to establish a scientifically sound program to study product stability;
• Failure to ensure that the water supplied by the city of Tianmen and used in manufacturing was suitable for that purpose;
• Failure to store materials so as to prevent contamination. One storage rack for finished API products was placed against a wall, hampering cleaning;
• Weaknesses in written procedures for handling OOS issues and in documentation of deviations;
• Disposal of construction refuse in long grass near the company’s perimeter fence, providing a harbor for pests;
• Lack of hot water in employee wash rooms; and
• Failure to adequately clean floor mops, which were stored head-down on a rack.