FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Taiwan Biotech Called Out for Environmental Monitoring

June 15, 2018
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The FDA warned finished drugmaker Taiwan Biotech for significant CGMP violations at its facility in Taoyuan City, Taiwan, including inadequate environmental monitoring.

The agency’s inspection in September revealed containers holding environmental microbiological samples with many lacking basic documentation such as colony-forming unit counts and who collected the samples.

“Your failure to accurately account for numerous environmental monitoring plates, enumerate the results and fully investigate the systemic flaws that led to the unreported data raises questions regarding the integrity of data generated by your firm,” the agency said.

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