Category: News

The News category provides timely updates on developments that shape GMP compliance across the pharmaceutical industry. It brings together regulatory changes, FDA and EMA communications, inspection findings, warning letters, and product recalls, highlighting how external events influence daily operations.

With clear context and analysis, this section supports proactive decision-making and helps companies remain aligned with global GMP standards.

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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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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...
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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...
USP-NF Pharmacopeial Forum 51 - Draft proposals

USP–NF Proposed Drafts in PF 51(2): Key Highlights and Industry Impact

Discover the key updates in USP–NF PF 51(2), including revisions to chromatography, analytical instrument qualification, microbial contamination control, solubility measurements,...
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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...
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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...
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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...
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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...

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