FDA Warns Chinese Devicemaker for Quality Failures
Failure to control nonconforming products landed Dongguan Microview Medical a warning letter following an FDA inspection of its facility in Guangdong, China. Source: The GMP Letter
Thai Condom Manufacturer Draws Warning for GMP Failures
The FDA slapped Thai condom manufacturer Okamoto Rubber Products with a warning letter after receiving an inadequate response to a 483 following an inspection of the firm’s Pathumthani site. Source:…
Hungarian Devicemaker Warned for Poor Design, Process Controls
The FDA issued a warning letter to a devicemaker in Pest, Hungary for serious quality system failures, including inadequate design and process controls. Source: The GMP Letter
European Commission Delays MDR for Another Year Due to COVID-19
The European Commission has adopted a proposal to delay implementation of the EU Medical Device Regulation (MDR) for a year due to the COVID-19 pandemic. Source: The GMP Letter
IMDRF Calls for Harmonized Approach for Adverse Event Reports, Cybersecurity
The International Medical Device Regulators Forum (IMDRF) released final guidance on harmonized regulations for adverse event reporting, cybersecurity, and personalized medical devices. Source: The GMP Letter
FDA Eases Supply Chain Requirements During Pandemic
To keep prescription drugs moving smoothly through the supply chain during the pandemic, the FDA released emergency final guidance exempting certain COVID-19 products from tracing and identification requirements. Source: Drug…
483 Roundup: FDA Cites Eight Firms for Quality Issues
The FDA found a range of quality lapses during inspections at eight U.S.-based plants. Source: Drug GMP Report
CDER Issues Staff Manual on the Newly Identified Safety Signal Process
CDER laid out how it will review newly identified safety signals (NISS) for marketed drugs, in a new Manual of Policies and Procedures (MAPP). Source: Drug GMP Report
Online Pharmacy Warned for Selling Unapproved COVID-19 Products
The FDA hit online pharmacy Unitedpharmacies.md with a warning letter for marketing on its website unapproved and misbranded products as COVID-19 treatments. Source: Drug GMP Report
Oregon Compounder Hit for Poor Aseptic Practices
The FDA issued a warning letter to an Oregon compounder for lax aseptic practices observed during an inspection of its facility. Source: Drug GMP Report
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