A warning letter has been issued by the US Food and Drug Administration summarising significant violations of current good manufacturing practice by the Taiwan-based pharmaceutical company
Taiwan Biotech Co. is under pressure from the US Food and Drug Administration (FDA) to improve its standards and manufacturing practices at its facility located in Taoyuan, Taiwan.
On 31 May, the US FDA sent a letter of warning to the company summarising "significant violations of good manufacturing practice (GMP) regulations for finished pharmaceuticals" and commented that the products failed to conform to the compendial standard.
The firm was reprimanded for "failing to establish an adequate system for monitoring environmental conditions in aseptic processing areas," which prevent contamination of drugs during manufacturing.
The FDA sent inspectors to the facility in Taoyuan in September 2017, and found that the "reported level of environmental control is dubious".
Inspectors also stated that the company "failed to follow an adequate written testing program designed to assess the stability characteristics of drug products" and it also failed to maintain adequate written records.
In response to the letter the pharmaceutical company has been asked to provide further details on environmental monitoring. And to provide risk assessments for any potentially affected products marketed to the US.
The company has also been ask to perform a thorough, independent assessment of environmental and personnel monitoring, laboratory, methods and equipment practices. And a comprehensive identification of all contamination hazards.
The FDA has advised that the company to consult with a GMP specialist to ensure compliance with US standards.
The letter concludes by stating that until Taiwan Biotech is in compliance with the GMP standards, the FDA may withhold approval of new product applications and may issue a complete refusal of products, manufactured at the Taoyuan facility for sale in the US.