Taiwan Biotech Co. reviewing practices after warning letter from US FDA

A warning letter was issued to the Taiwanese pharmaceutical company May 31, asking them to take quick steps to remedy violations of Good Manufacturing Practices

Image from Pixabay user Ajale

Image from Pixabay user Ajale

TAIPEI (Taiwan News) – One of the largest pharmaceutical companies in Taiwan is under pressure from the U.S. Food and Drug Administration to step up their standards and manufacturing practices at their facility, located in Taoyuan.

On May 31, the U.S. FDA sent a letter of warning to Taiwan Biotech Company summarizing “significant violations of good manufacturing practice (GMP),”and asking them to take steps towards remedying the problems within the first half of June.

The FDA warned the company after discovering “dubious” record keeping related to the environmental monitoring system of the company’s aseptic processing facilities, which prevent contamination of drugs during manufacturing.

The FDA sent inspectors to the facility in Taoyuan in September 2017, and found that the firm failed to establish sound lab procedures for testing drug products and keeping detailed records.

The primary areas of short-comings listed in the FDA letter are failures to; “establish an adequate system for monitoring environmental conditions in aseptic processing areas; and to follow an adequate written testing program designed to assess the stability characteristics of drug products.”

Further, Taiwan Biotech “failed to maintain written records so that data therein could be used for evaluating, at least annually, the quality standards of each drug product to determine the need for changes in drug product specifications or manufacturing or control procedures.”

The FDA has advised the company to consult with a GMP specialist to ensure compliance with U.S. standards.

The letter closes by stating that until Taiwan Biotech is in compliance with the GMP standards, the FDA may withhold approval of new product applications, and may eventually issue a complete refusal of products manufactured at the Taoyuan facility for sale in the United States.

The letter was issued to Taiwan Biotech on May 31, and stipulated that correspondence was expected within the first half of June to address what steps the company had made to address the violations.