FDA hits Taiwan Biotech with warning letter
- Following an inspection in September 2017, Taiwan Biotech's Taoyuan City plant has received a warning letter from the Food and Drug Administration over significant violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals.
- The FDA took issue with the plant's environmental monitoring conditions in aseptic processing areas, as well as its assessment of drug stability or quality.
- In their warning, regulators recommended Taiwan Biotech recruit a cGMP consultant. The drugmaker had 15 working following receipt of the warning to submit a response.
The FDA's been on a warning letter tear as of late. Its one to Taiwan Biotech, dated May 31, is the 45th from the the Center for Drug Evaluation and Research (CDER) published on the agency's site this year. That's a step up from 2017, when the FDA published 31 CDER warning letters from the beginning of January to the end of May.
These actions have largely targeted drugmakers located in Asia. Many manufacturers there, particularly in China and India, have tried to expand their presence and clout on the global stage, but the U.S. regulator remains wary of what it frequently classifies as subpar safety and production practices.
During its inspection of Taiwan Biotech's Taoyuan City facility, the FDA noticed environmental monitoring plates that exceeded action limits, yet the company had not started a formal investigation of these problems. Documentation was also missing, fueling skepticism about a report in which Taiwan Biotech claimed it had cited all environmental monitoring deviations.
"Notably … your firm had reported no results outside limits for over a year prior to the inspection date," the warning letter stated. "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 had not been enumerated and recorded."
The inspection also spotted that the company had not collected required surface samples during the period of the inspection, which had been going for as long as two years.
The inspection revealed too that Taiwan Biotech failed to follow a testing program designed to assess the stability characteristics of drug products at the specified intervals. The company said it had revised its standard operating procedures, but failed to provide these or a retrospective analysis. The FDA now requires a retrospective review, and comprehensive assessments.
Finally, Taiwan Biotech did not maintain written records for evaluation of quality standards, and did not provide a sufficient response to the violation. The FDA has requested manufacturing and quality data for each drug marketed to the U.S., along with a risk assessment and a management strategy for corrective and preventive actions.
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