Taiwan Facility Receives FDA Warning Letter

FDA sent a warning letter, dated May 29, 2019, to Vida International after an inspection of the company’s Taoyuan City, Taiwan facility found a number of quality control issues. These violations of current good manufacturing practices (CGMPs) included failure to perform appropriate laboratory testing.

During the inspection, which was conducted from Dec. 10–13, 2018, investigators discovered that the company had failed to test for the identity, strength, purity, and quality of APIs as well as not testing for critical microbial attributes before releasing over-the-counter (OTC) products. The company also failed to test the identity of each component in its drug products, according to the agency. “Furthermore, you failed to determine whether each component conformed with all appropriate written specifications for purity, strength, and quality before using them,” the agency stated in the letter. 

An adequate quality control unit was also lacking, according to the letter. Written procedures were not properly established for a variety of quality functions including the release of product batches and the oversight of drug stability. “In addition, your firm drafted forms to document activities such as raw material receipt, change control, deviations, complaints, recalls, equipment cleaning, and employee training. However, you had not yet implemented these forms or established written procedures to describe the activities therein,” FDA stated.

While the company informed FDA of its intentions to stop shipping products to the United States, the agency stated in the letter that more information regarding remediation of the company’s operations was needed. FDA asked the company to provide a plan for testing retain samples of all batches of drugs distributed to the US and perform a risk assessment on the products distributed to the US.

FDA placed the company on Import Alert 66-40 on March 11, 2019. “Until you correct all violations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer,” the agency stated.

Source: FDA