FDA’s Teva Warning Letter Sets Agenda For Investigating, Remedying Sterility Failures
FDA has published a warning letter that not only provides detailed guidance for Teva’s ongoing remediation of sterility assurance failures at a plant in Godollo, Hungary, but also suggests a game plan for any manufacturer of sterile drug products that’s seeing signs of issues with aseptic operations.
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A review of recent US FDA citations has industry concerned about the extent to which agency investigators may be reviewing security video archives as part of their pharmaceutical manufacturing plant inspections.
Many of the 30 drug product firms that received FDA warning letters in 2016 were foreign cosmetics and hygiene manufacturers that appeared to need education on US GMP requirements. Another major focus in letters to drug product firms last year was sterility assurance in the US and abroad.
The US Food and Drug Administration is writing shorter drug GMP warning letters in an effort to issue them more quickly.