Tag: Aseptic Practices

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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 Warns Aspen SA Sterile Operations for CGMP Violations in Lab Controls, Aseptic Practices, Data Integrity, and Environmental Monitoring

The FDA has issued a warning letter to Aspen SA Sterile Operations for serious CGMP violations, including failures in lab...

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