The FDA issued Taiwan Biotech a warning letter, citing a number of issues with the company’s quality-control unit.
In a letter posted on the regulatory agency’s website, the FDA said an inspector uncovered problems with the Taiwanese drugmaker’s quality-control unit during an inspection of the plant in early September 2017. It said the company didn’t provide an adequate system for monitoring environmental conditions in aseptic processing areas.
Taiwan Biotech, which was founded in 1945, produces drugs for the treatment of cardiovascular, diabetic, respiratory and eye care disease, according to its website.
During the inspection, the FDA found “numerous samples lacked basic documentation, including missing colony-forming unit (CFU) counts and the identity of the person who collected the sample,” the agency wrote, adding that a microbiology technician failed to collect required surface samples.
Additionally, Taiwan Biotech was cited for not following an adequate written testing program designed to assess the stability characteristics of drug products, and for failing to keep written records for the evaluation of the quality standards of each drug it produces in order to track drug product specifications and manufacturing and control procedures.
“Significant findings in this letter indicate that your quality unit is not able to fully exercise its authority and/or responsibilities,” the FDA wrote. “Your firm must provide the quality unit with appropriate authority and sufficient resources and staff to carry out its responsibilities and consistently ensure drug quality.”