Taiwanese Drugmaker Cited for Lax Testing
The FDA hit Vida International’s drug manufacturing facility in Taoyuan City, Taiwan with a warning letter for serious quality violations including inadequate drug testing.
The warning stemmed from a Dec. 10-13, 2018 inspection that found the firm released an OTC drug to the U.S. without testing for identity, strength, purity and quality. The FDA investigators also found that incoming raw materials including active ingredients and other components weren’t tested to verify their identity.
The agency cited the facility’s quality control unit for lacking many written procedures, such as for releasing drug product batches and oversight of drug stability. In addition, the facility had forms for documenting activities like change control, raw material receipt, deviations, complaints, recalls, equipment cleaning and employee training, but lacked written procedures for implementing them.