Taiwan Biotech gets FDA warning letter over quality-control issues

An FDA inspector uncovered problems with the drugmaker’s quality-control unit in September 2017. (FDA)

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.

Free Daily Newsletter

Like this story? Subscribe to FiercePharma!

Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them. Sign up today to get pharma news and updates delivered to your inbox and read on the go.

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.”

Suggested Articles

Boehringer Ingelheim intends to make a significant investment in its three manufacturing sites in Mexico in the next three years.

Dendreon has signaled faith in its struggling prostate drug Provenge by signing a 10-year lease extension for its California manufacturing facility.

Daiichi Sankyo says it still unable to fulfill a government mandate to be able to produce enough H5N1 flu vaccine to fight an epidemic in Japan.