Austin Biotechnology hit with US FDA warning at Taipei facility

By Dan Stanton

- Last updated on GMT

Image: iStock/Pontuse
Image: iStock/Pontuse

Related tags: Food and drug administration, Pharmaceutical drug

The Taiwanese drugmaker stopped shipping products to the US after an FDA inspection but failed to commit to corrective actions, states a warning letter published this week.

The US Food and Drug Administration (FDA) inspected Austin Biotechnology’s facility in Taipei, Taiwan in May 2015 but failure to correct a number of cGMP violations led to a warning letter issued earlier this month and published by the Agency yesterday.

Agency inspectors observed a number of violations, the letter said​, including the firm’s failure to establish a responsible quality control unit, written procedures for production and process controls, and a written testing program designed to assess the stability characteristics of drug products.

Drug products which bore an expiration date were not supported by appropriate stability testing, the FDA noted, and Austin Biotechnology was also found to have failed to withhold from use each lot of components, drug product containers, and closures until the lot has been sampled, tested, or examined.

“In your response of May 29, 2015, you acknowledged the significance of the CGMP observations and ‘decided to stop the shipping and distribution of these products in the USA,’”​ the Agency said. “You did not commit to any corrective actions regarding the CGMP violations observed on the inspection.”

The FDA also advised the drugmaker to engage a qualified consultant to assist in bringing the facility up to cGMP requirements, if the firm intends to resume manufacturing for the US market.

The warning comes a week after the FDA published details of another Taiwanese drugmaker hit with cGMP issues.

Ko Da Pharmaceutical’s facility in Taoyuan City​ received a Warning Letter last month after the Agency found problems with the firm’s quality control unit during an inspection last year.

Related topics: QA/QC, Regulations, Markets & Regulations

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