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GMP News

FDA Warning Letter Highlights OOS Handling and Stability Failures

In late September 2025, the FDA published a new Warning Letter describing significant deficiencies at an OTC drug manufacturer. Inspectors identified critical issues related to data integrity, OOS investigations, stability testing, process validation, and quality oversight.

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Pharmeuropa: Revision of Residual Solvents Chapter 2.4.24 Published for Comments

The European Pharmacopoeia has published a fully revised draft of Chapter 2.4.24. Identification and control of residual solvents in Pharmeuropa 37.4 for public consultation.

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US FDA Warning Letter: Inadequate Investigation of Complaints

The U.S. FDA issued now a Warning Letter (WL) to a South Korean company after having inspected its site in November 2024. According to U.S. FDA Warning Letter, the firm failed to do "adequate investigations of recurring complaints" related to their finished products' packaging materials, even so these complaints occurred more than one time.

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