Tag: Warning Letter

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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...
fda-warning-letter-analysis

FDA Warns Linghai ZhanWang for Unsafe Materials, Stability Failures, and Poor Oversight

FDA issues a warning letter to Linghai ZhanWang for failing raw material testing, stability studies, and quality oversight, placing its...
fda-warning-letter-analysis

FDA Warning Letter Analysis: Chem-Tech, Ltd. – Deficiencies in OOS Investigation, Cleaning Validation and More

FDA issues a warning letter to Chem-Tech, Ltd. for improper OOS investigations, unvalidated cleaning procedures, and poor quality oversight. Key...
fda-warning-letter-analysis

FDA Warning Letter: Marshalls Traditional Healthcare CC

CGMP violations identified in the FDA Warning Letter to Marshalls Traditional Healthcare CC, including deficiencies in finished product testing, process...
fda-warning-letter-analysis

FDA Issues Warning Letter to ABR Laboratory LLC Over Quality Control Failures

FDA warns ABR Laboratory LLC for failing to validate test methods and investigate deviations, risking drug safety. Learn key compliance...
fda-warning-letter-analysis

FDA Issues Warning Letter to Strukmyer Medical Highlighting Serious CGMP Deficiencies

On January 30, 2025, the FDA issued a Warning Letter (320-25-37) to Strukmyer LLC dba Strukmyer Medical, following an inspection...

fda-warning-letter-analysis

FDA Highlights Systemic Issues at Mylan Laboratories in Recent Warning

FDA warns Mylan Laboratories for critical cGMP violations in quality control, data integrity, and governance, urging urgent corrective actions to...
fda-warning-letter-analysis

FDA Warning Letter: MedOffice Saglik Endustri Anonim Sirketi

he FDA inspection at MedOffice Saglik Endustri Anonim Sirketi revealed significant CGMP violations that could jeopardize product quality and consumer...
fda-warning-letter-analysis

FDA Warning Letter Analysis: Diamond Chemical Co., Inc.

FDA issues a Warning Letter to Diamond Chemical Co., Inc. for cGMP violations, highlighting deficiencies in component testing, batch release,...
FDA Issues Warning Letter to LS Promotions INC. for cGMP Violations

FDA Issues Warning Letter to LS Promotions Inc. for cGMP Violations

FDA issues warning to LS Promotions Inc. for significant cGMP violations. Learn about the key deficiencies, recommended CAPA plan, and...

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