Medical Device Recalls – Early Alerts System (FDA Pilot Expansion)
On 29 September 2025, the FDA announced that the pilot program for rapid medical device recall communications (the…
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Counterfeit Drugs: A Growing Problem
Counterfeit drugs (fake pharmaceuticals and adulterated medicines) are a growing problem around the globe. It is estimated that…
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Changes to PIC/S GMP
What updates or changes to PIC/S GMP Guidance do you need to understand; and what is the latest version of PIC/S GMP Guidance and PIC/S Annexes?
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Top 10 GMP Audit Citations: FDA & TGA Inspections
FDA & TGA GMP Compliance Audit Citations for 2020 – 2024. Latest FDA inspection trends: common audit findings…
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FDA Warning Letters on Data Integrity Issues
Batch release decisions — and other product safety evaluations — rely on data integrity. In this pharmaceutical industry…
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Get ready for an Audit
Get ready for an audit (how to train your employees) Need to get ready for an audit? How…
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Remote Inspections (Offsite Inspections)
Remote inspections: FAQs Remote Inspections & Offsite Auditing 10 Commandments for Conducting Remote Inspections (offsite inspections) FAQ 1:…
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Medical Supply Chain Risks: Vulnerabilities and the Importance of GMP
Lean manufacturing and ‘just in time’ shipping strategies means medical supply chain risks are an ever-present phenomenon. But medical…
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Does my product require FDA approval?
FDA Pre-Approval Requirements Will your product need pre-approval from the FDA before you can sell it to the…
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