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.
When asked by the investigator for environmental monitoring limit deviations, the firm had no results for outside limits for more than a year prior to the inspection date. The agency questioned the firm’s reported level of environmental control because during the inspection several environmental monitoring samples were found to have experienced significant growth and were not counted or recorded.
The investigator also found that the facility’s microbiology technician had neglected to collect necessary surface samples for a week prior to the inspection. The firm’s management admitted that deficient environmental monitoring had occurred for one to two years.
The firm also did not conduct ongoing stability testing at proper intervals as required by its stability program. In September 2016, it failed to perform testing at the 12-month stability time interval for one of its batches and performed 6-month stability testing for another batch four months late. It also failed to investigate the missed and delayed stability testing.
The agency called for a comprehensive investigation into the inaccuracies and a risk assessment of potential effects of the failures on drug quality.