Home » Wuhan Warned for Quality Controls, Adulterated Products
Wuhan Warned for Quality Controls, Adulterated Products
Drugs Inspections and Audits
The FDA issued Wuhan Chinese Moxibustion Technology a warning letter for manufacturing adulterated products, and for quality and sanitation deficiencies.
In an inspection of the Wuhan, Hubei facility last May, the agency found that the company lacked numerous basic written procedures for drug manufacturing, including for current GMP training, annual product reviews, and recalls for U.S. products.
The investigator also found the firm lacked master production and control records for products that included the speed, time and the order of component addition, and the production records did not include adequate instructions for use.