FDA: Key FY 2019 Warning Letter Trend Is Inadequate Testing For API Impurities
This year’s 89 warning letters so far hit API testing for nitrosamines, aseptic facility design, contaminated water, API traceability and more.
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To reduce the opportunity for data integrity failures in the microbiology lab, manufacturers should map out the workflow so that activities and expectations for employees are clearly spelled out. Having formalized processes will ensure that employees don’t cut corners.
Industry is still having major problems in this area despite the FDA's exhaustive 2006 OOS guidance.
Agency demands review of invalidated out-of-specification findings as root causes of failures continue to elude Indian drugmaker at multiple facilities.