Tag: FDA

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FDA Inspection Readiness Guideline: How to prepare for unannounced global audits

FDA Inspection Readiness: How to Prepare for Unannounced Global Audits

Discover global strategies for FDA Inspection Readiness, real-time GMP compliance, and regulatory confidence....
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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: 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FDA Draft Guidance: Considerations for Complying with 21 CFR 211.110

FDA Draft Guidance: Considerations for Complying with 21 CFR 211.110

FDA's January 2025 draft on 21 CFR 211.110 outlines CGMP measures for batch uniformity, drug integrity, and advanced manufacturing innovation...
FDA's Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices

FDA Transitional Enforcement Guidance for Ethylene Oxide Sterilization Facility Changes for Class III Devices

FDA announces a new policy on ethylene oxide sterilization site changes for Class III devices, ensuring supply chain stability and...
Introduction to Good Manufacturing Practices (GMP)

What Is Good Manufacturing Practices (GMP)?

Good Manufacturing Practice (GMP) ensures pharmaceuticals are produced consistently with high standards for quality, safety, and efficacy, protecting patient health....
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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,...

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