Taiwanese Drugmaker Earns Warning Letter Over GMP Violations

Another Taiwanese drugmaker is in the hot seat over quality control deficiencies, landing a warning letter for a host of GMP violations.  

During an inspection of Austin Biotechnology’s Taipei facility, inspectors concluded that the firm lacked a quality control unit to ensure product integrity. This discovery triggered another complaint: the company was releasing these products without first being sampled, tested or examined by quality control personnel.

The letter also said that Austin did not ensure that its drugs included an expiration date that was supported by appropriate stability testing, and it failed to establish and follow a written testing program to assess the stability of its drugs.