The US Food and Drug Administration (FDA) has issued a warning letter to Taiwan Biotech Company after it inspected the firms’ drug manufacturing facility in Taoyuan City, Taiwan.
According to the warning letter, FDA inspectors – who visited the facility in September 2017 – observed good manufacturing practice (GMP) violations, including an inadequate environmental monitoring system in the firm’s aseptic processing areas.
The environmental control system is designed to prevent and control contamination at specific stages of the drug manufacturing process.
When requested to provide records of deviations from environmental monitoring limits, Taiwan Biotech reported no irregularities for more than a year prior to the inspection date.
“This reported level of environmental control is dubious, in that during the current FDA inspection, several environmental monitoring samples were found to have significant growth, and these results have not been enumerated and recorded,” according to the agency.
In addition, upon finding containers storing microbiological samples, the inspector observed that “numerous samples lacked basic documentation, including missing colony-forming unit (CFU) counts and the identity of the person who collected the sample.”
The FDA also flagged Taiwan Biotech’s failure to conduct ongoing stability testing, and maintain written records to evaluate the quality of drug standards.
“Your annual product reviews (APR) only included batches shipped to the US and the associated deviation investigations. The APR did not include batches shipped to countries other than the US, but manufactured under the same conditions,” said the FDA.
The agency has recommended the firm employ a GMP consultant to address these concerns.
Taiwan Biotech did not respond to a request for comment.