Tag: FDA Warning Letter

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fda-warning-letter-analysis

FDA Warning Letter to Somerset Therapeutics Pvt. Ltd. (India) Issued September 2025

FDA issues Warning Letter to Somerset Therapeutics citing major cGMP failures in aseptic practices, investigations, and reporting....
fda-warning-letter-analysis

FDA Issues Warning Letter to Yangzhou Sion Commodity Co., Ltd.

FDA warns Yangzhou Sion for CGMP violations, citing failures in component testing, QC oversight, and data integrity. CAPA plan and...

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